Devices, systems, and methods for the treatment of vascular defects

ABSTRACT

Devices, systems, and methods for treating vascular defects are disclosed herein. One aspect of the present technology, for example, is directed toward an occlusion device that includes a proximal portion, a distal portion, and an intermediate portion extending between the proximal portion and the distal portion. The distal portion can include a directing region and a lead-in member that extends distally from the directing region. When the occlusion device is in a deployed configuration, the intermediate portion can form a preset bend in the occlusion device that positions the directing region at an angle with respect to the proximal portion. As a result, as the occlusion device is pushed distally out of a delivery catheter into the aneurysm, the directing region directs the distal portion away from exiting the aneurysm through the neck such that the proximal portion crosses the neck and generally remains within the aneurysm.

TECHNICAL FIELD

The present technology is directed generally to devices, systems, andmethods for the treatment of vascular defects.

BACKGROUND

Aneurysms are blood-filled dilations of a blood vessel generally causedby disease or weakening of the blood vessel wall. The wall of theaneurysm may progressively thin, which increases the risk of rupturecausing hemorrhagic stroke or even sudden death. There are about 30,000to 40,000 cases of aneurysmal rupture per year in the United States,accounting for about 5% of all strokes. The prognosis after aneurysmalrupture is poor; the 30-day mortality rate is approximately 45% and apositive functional outcome is achieved in only 40-50% of survivors.Traditional approaches to preventing aneurysmal rupture often includepacking the aneurysm with metal coils to reduce the inflow of blood tothe aneurysm and prevent further enlargement and rupture. Such coils areoften referred to as “embolic coils” or “microcoils,” and can becategorized into the following three groups based on their structuralproperties: framing coils, filling coils, and finishing coils. Framingcoils are inserted first into the aneurysm and form the base structureinto which the later-delivered filling coils are packed. As such,framing coils are stiffer than filling and finishing coils to providestructural stability and generally have a complex or three-dimensionalshape for approximating the periphery of the aneurysm. Filling coils, incontrast, are softer than framing coils, and multiple filling coils arepacked within the framework of the framing coil(s) to achieve a highpacking density. Finishing coils are delivered last to fill anyremaining gaps left between filling coils.

Embolic coils, however, have several drawbacks. First, embolic coilsgenerally only achieve a 20-40% packing density (i.e., ratio of thevolume of the coils inserted into the aneurysm sac and the volume of theaneurysm sac). As a result, blood continues to flow into the aneurysm(also known as recanalization) in about 30% of coil cases, which cancause further swelling of the aneurysm over time. In addition, becausethe coils must be very small to fit within a microcatheter for deliverythrough the tiny cranial vessels, numerous coils are often required toadequately fill the aneurysm. These numerous coils must be deliveredone-by-one, thereby increasing procedure time and complexity. Yetanother drawback is that embolic coils cannot accommodate the wide rangeof aneurysm shapes and sizes. Embolic coils, for example, are difficultto stabilize within wide-necked aneurysms, which can result in migrationof one or more coils across the neck such that a portion of the migratedcoil(s) protrudes into the parent blood vessel. The protruding portionof the migrated coil(s) can be a nidus for thromboembolism, which can befatal if left unaddressed. To address this shortcoming, many existingtreatments include positioning an intracranial stent across the neck ofthe aneurysm to prevent all or part of a coil from migrating across theneck. However, intracranial stents can also be a nidus forthromboembolism, and further increase procedure time and cost. Thus,there is a need for improved devices, systems, and methods for treatinganeurysms.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an isometric view of an occlusion device in a deployedconfiguration in accordance with an embodiment of the presenttechnology.

FIG. 1B is a top view of the occlusion device shown in FIG. 1A, unfurledand held in an elongated configuration.

FIG. 1C is a schematic illustration showing cross-sections of theocclusion device at different locations along the longitudinal axis ofthe occlusion device.

FIG. 2 is a side view of the occlusion device of FIGS. 1A-1B while beingdeployed from a delivery catheter in accordance with an embodiment ofthe present technology.

FIG. 3A is a top view of a portion of the occlusion device of FIGS.1A-1B being deployed from a delivery catheter configured in accordancewith an embodiment of the present technology.

FIG. 3B is a side view of the portion of the occlusion device shown inFIG. 3A from the view indicated by view indicator “FIG. 3B.”

FIGS. 4A-4E are partial schematic illustrations showing a method fordeploying an occlusion device within an aneurysm in accordance with anembodiment of the present technology.

FIG. 5 schematically illustrates an occlusion device without thestructure of the present technology for preventing re-entering a lumenof a blood vessel adjacent a targeted aneurysm during delivery of theocclusion device to the targeted aneurysm.

FIG. 6 shows a portion of an occlusion device in accordance with anembodiment of the present technology.

FIG. 7 shows a portion of an occlusion device in accordance with anotherembodiment of the present technology.

FIG. 8 shows a portion of an occlusion device in accordance with afurther embodiment of the present technology.

FIG. 9 shows a portion of an occlusion device in accordance with yetanother embodiment of the present technology.

FIG. 10 shows a portion of an occlusion device in accordance withanother embodiment of the present technology.

FIG. 11 shows a portion of an occlusion device in accordance withanother embodiment of the present technology.

FIG. 12 shows a portion of an occlusion device in accordance withanother embodiment of the present technology.

FIG. 13A is a schematic illustration of a medical device according to anembodiment in a first configuration.

FIG. 13B is a schematic illustration of a medical device according to anembodiment in a second configuration.

FIG. 14A is a side view of a medical device according to an embodimentin a first configuration.

FIG. 14B is a side view of a medical device according to an embodimentin a second configuration.

FIG. 14C is a view of the medical device of FIG. 14A in a firstconfiguration during insertion into an aneurysm.

FIG. 14D is a view of the medical device of FIG. 14A in a secondconfiguration during insertion into an aneurysm.

FIG. 14E is a view of the medical device of FIG. 14A in a thirdconfiguration during insertion into an aneurysm.

FIG. 15 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIGS. 16-22 are views of a medical device in an expanded configuration,according to embodiments.

FIG. 23A is a view of a medical device in a partially collapsedconfiguration, according to an embodiment.

FIG. 23B is a view of the medical device of FIG. 23A in an expandedconfiguration, according to an embodiment.

FIG. 24 is a view of a portion of a medical device in an expandedconfiguration according to an embodiment, with a first portion spacedapart from a second portion.

FIG. 25A is a view of a portion of a medical device in a collapsedconfiguration according to an embodiment.

FIG. 25B is a view of a portion of a medical device in an expandedconfiguration according to an embodiment.

FIG. 26A is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 26B is a schematic illustration of the medical device of FIG. 26A.

FIG. 27 is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 28A is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 28B is a view of a portion of the medical device of FIG. 28A in acollapsed configuration.

FIG. 29A is a view of a portion of a medical device in a collapsedconfiguration, according to another embodiment.

FIG. 29B is a view of the portion of the medical device of FIG. 29A inan expanded configuration.

FIG. 30A is a view of a portion of a medical device in a collapsedconfiguration, according to an embodiment.

FIG. 30B is a view of the portion of the medical device of FIG. 30A in apartially expanded configuration.

FIG. 30C is a view of a portion of the medical device of FIG. 30A in anexpanded configuration.

FIGS. 31A and 31B are each a different view of a portion of a medicaldevice in an expanded configuration, according to an embodiment.

FIGS. 32 and 33 are each a view of a portion of a medical device in anexpanded configuration, according to different embodiments.

FIG. 34A is a view of a portion of a medical device in a collapsedconfiguration, according to an embodiment.

FIG. 34B is a view of the portion of the medical device of FIG. 34A,shown in an expanded configuration.

FIG. 34C is a schematic illustration of the portion of the medicaldevice of FIG. 34B.

FIG. 35A is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 35B is a view of a portion of the medical device of FIG. 35A in acollapsed configuration.

FIG. 36A is a view of a portion of a medical device in an expandedconfiguration, according to an embodiment.

FIG. 36B is a view of a portion of the medical device of FIG. 36A in acollapsed configuration.

FIG. 36C is a view of a portion of the medical device of FIG. 36A shownpartially deployed within an aneurysm.

FIG. 37A is a schematic illustration of a portion of a medical deviceshown in a collapsed configuration, according to another embodiment.

FIG. 37B is a view of the portion of the medical device of FIG. 37A,shown in an expanded configuration.

FIG. 38 is a schematic illustration of a portion of an occlusion device,according to another embodiment, shown in a collapsed configuration.

SUMMARY

An aspect of at least some of the embodiments disclosed herein involvesan occlusion device having a preset bend at its distal portion thatpositions a directing region of the occlusion device at an angle withrespect to a proximal portion of the occlusion device. As the occlusiondevice is pushed distally out of a delivery catheter (e.g., amicrocatheter) into an aneurysm, the directing region positions thedistal portion such that the proximal portion generally remains withinthe aneurysm.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as numbered clauses (1, 2, 3, etc.) forconvenience. These are provided as examples and do not limit the subjecttechnology. It is noted that any of the dependent clauses may becombined in any combination, and placed into a respective independentclause, e.g., clause 1, 8, 22, 32, 40, 47, 56, 65, or 69. The otherclauses can be presented in a similar manner.

1. A vascular occlusion device for treating an aneurysm, wherein a neckof the aneurysm opens to a blood vessel, the device comprising:

-   -   a proximal portion having a mesh configured to be positioned        within the aneurysm;    -   a distal portion including a directing region having:        -   a proximal terminus that coincides with a proximal terminus            of the distal portion,        -   a distal terminus, wherein the directing region extends            along a first direction that runs through the proximal            terminus and the distal terminus, and        -   a length measured along the first longitudinal direction            between the proximal terminus and the distal terminus; and    -   an intermediate portion between the proximal and distal portions        that, when in a deployed configuration, forms a preset bend in        the device that orients the first longitudinal direction of the        directing region at an angle to a portion of the proximal        portion adjacent the intermediate portion, and    -   wherein, when the device is being pushed distally out of a        delivery catheter into the aneurysm, the directing region        directs the distal portion to inhibit the distal portion from        exiting the aneurysm through the neck such that the proximal        portion crosses the neck and generally remains within the        aneurysm.

2. The device of Clause 1 wherein the directing region includes anelongated, generally cylindrical portion of the mesh.

3. The device of Clause 1 wherein:

-   -   the intermediate portion includes a portion of the mesh having a        preset, curved shape; and    -   the directing region includes an elongated, generally        cylindrical portion of the mesh.

4. The device of any one of Clauses 1-3 wherein the directing region hasa generally linear shape.

5. The device of any one of Clauses 1-4 wherein the proximal portion hasa second longitudinal direction immediately adjacent the intermediateportion, and wherein the angle is between the first longitudinaldirection of the directing region and the second longitudinal directionof the proximal portion.

6. The device of any one of Clauses 1-5 wherein the mesh is a braid.

7. The device of any one of Clauses 1-6 wherein the length of thedirecting region is from about 25% to about 75% of a diameter of theaneurysm.

8. The device of any one of Clauses 1-7 wherein the length of thedirecting region is between about 0.05 inches and about 0.20 inches.

9. The device of any one of Clauses 1-7 wherein the length of thedirecting region is between about 0.021 inches and about 0.20 inches.

10. The device of any one of Clauses 1-7 wherein the length of thedirecting region is between about 0.021 inches and about 0.18 inches.

11. The device of any one of Clauses 1-10 wherein the angle is betweenabout 45 degrees and about 135 degrees.

12. The device of any one of Clauses 1-10 wherein the angle is betweenabout 65 degrees and about 115 degrees.

13. The device of any one of Clauses 1-10 wherein the angle is betweenabout 70 degrees and about 110 degrees.

14. The device of Clause 1 wherein the angle is between about 80 degreesand about 105 degrees.

15. A vascular occlusion device for treating an aneurysm, wherein a neckof the aneurysm opens to a blood vessel, the device comprising:

-   -   an expandable mesh having an elongated configuration and a        deployed configuration, wherein, in the deployed configuration,        the mesh includes:        -   a proximal portion formed of a flattened tubular braid            configured to contact and conform to an inner surface of the            aneurysm,        -   a radially compacted distal portion,        -   an intermediate portion extending between the proximal            portion and the distal portion, wherein the intermediate            portion is curved such that the distal portion is positioned            at a predetermined angle with respect to the proximal            portion; and    -   a directing region at the distal portion of the expandable mesh        having a proximal terminus and a distal terminus, wherein the        directing region extends along a first longitudinal direction        that runs through the proximal terminus and the distal terminus,        and wherein the directing region is positioned at an angle        relative to the proximal portion between about 45 degrees and        about 135 degrees, and    -   wherein, when the device is being pushed distally out of a        delivery catheter into the aneurysm, the directing region        directs the distal portion to inhibit the distal portion from        exiting the aneurysm through the neck such that the proximal        portion crosses the neck and generally remains within the        aneurysm.

16. The device of Clause 15 wherein the directing region includes anelongated, generally cylindrical portion of the mesh.

17. The device of Clause 15 or Clause 16 wherein the directing regionhas a generally linear shape.

18. The device of any one of Clauses 15-17 wherein the proximal portionof the mesh forms a predetermined three-dimensional structure when themesh is in a deployed configuration.

19. The device of any one of Clauses 15-18 wherein the proximal portionof the mesh forms a plurality of curved, broad portions that togetherform a three-dimensional spherical structure when the mesh is in thedeployed configuration.

20. The device of any one of Clauses 15-19 wherein, when the mesh is inthe deployed configuration, the proximal portion of the mesh forms (1) afirst plurality of concave, broad portions that together form a firstthree-dimensional structure, and (2) a second plurality of concave,broad portions that together form a second three-dimensional structurethat is configured to be deployed within an interior region defined bythe first three-dimensional structure.

DETAILED DESCRIPTION

The present technology is directed generally to devices, systems, andmethods for the treatment of vascular defects, and in particular, tovascular occlusion devices for treating hemorrhagic stroke. Unlikeconventional devices, the occlusion device of the present technology isdeliverable through a microcatheter, self-anchors within the aneurysm,and provides improved neck coverage. In one embodiment, the presenttechnology includes an expandable occlusion device having a proximalportion, a distal portion, and an intermediate portion extending betweenthe proximal portion and the distal portion. The distal portion of theocclusion device can include an elongated directing region and a lead-inmember that extends distally from the directing region. The directingregion can have a length that is about 25% to about 75% of a diameter ofthe targeted aneurysm. In operation, as the occlusion device isinitially deployed from the delivery catheter, the intermediate portionforms a preset bend in the occlusion device that positions the directingregion at an angle with respect to the proximal portion. As theocclusion device is pushed further distally out of a delivery catheter(e.g., a microcatheter) into the aneurysm, the directing regionpositions the distal portion such that the proximal portion generallyremains within the aneurysm. For example, the directing region candirect the distal portion to consistently span across or even away fromthe neck of the aneurysm.

As used herein, the terms “distal” and “proximal,” unless otherwisespecified, refer to a position of the occlusion device and/or portionsof the occlusion device relative to an operator along a longitudinalaxis of the occlusion device, and/or a position of associated deliverycomponents (or portions thereof) relative to an operator along alongitudinal axis of the relevant delivery component.

1.0 Overview

FIG. 1A is an isometric view of an occlusion device 100 in accordancewith the present technology shown in a deployed (e.g., unsheathed)configuration in which it is not constrained (e.g., relaxed). FIG. 1B isa top view of the occlusion device 100 after being unfurled from thedeployed, relaxed configuration shown in FIG. 1A and held in anunfurled, elongated configuration to provide a better view of the entirelength of the occlusion device 100. As shown in FIGS. 1A and 1B, theocclusion device 100 includes a mesh 101, a lead-in member 102, aproximal connector 105 (FIG. 1B), and a distal connector 103 couplingthe lead-in member 102 to the mesh 101. The mesh 101 is formed of asuperelastic and/or shape memory material. The properties of thesematerials allow the device to deform and be constrained within adelivery catheter in a low-profile configuration (not shown) and thenreturn to a preset deployed configuration (FIG. 1A) upon release fromthe delivery catheter. In other embodiments, the mesh can be formed ofan elastic material or other suitable self-forming material capable ofmoving into a desired shape upon release from the delivery catheter.

As best shown in FIG. 1B, the occlusion device 100 includes a proximalportion 104, a distal portion 108, and an intermediate portion 106extending between the proximal portion 104 and the distal portion 108.In both the deployed configuration shown in FIG. 1A and the unfurledconfiguration shown in FIG. 1B the occlusion device 100 has alongitudinal dimension L (shown in dashed lines) extending generallyalong a midline or medial area through the proximal portion 104, theintermediate portion 106, and the distal portion 108 (only a portion ofthe longitudinal dimension L is labeled in FIG. 1A). The occlusiondevice 100 is configured to be arranged in the delivery catheter (notshown) such that the distal portion 108 deploys first, which is followedby the intermediate portion 106 and then the proximal portion 104.

In the embodiment of the occlusion device 100 shown in FIGS. 1A and 1B,the mesh 101 comprises the proximal portion 104 of the occlusion device100. The mesh 101 has a proximal end portion 107 (FIG. 1B) coupled tothe proximal connector 105 (FIG. 1B) and a distal end portion 109 (FIG.1B) coupled to the distal connector 103. In the embodiment shown inFIGS. 1A and 1B, the mesh 101 includes a plurality of curved, broadportions 110 positioned along the longitudinal dimension L, and aplurality of narrow portions 112 individually positioned betweenadjacent broad portions 110 along the longitudinal dimension L. The mesh101 is configured such that, when the mesh 101 is in the deployed,relaxed configuration, the broad portions 110 assume a layered,spherically-shaped arrangement, as shown in FIG. 1A. Individual broadportions, for example, can be positioned over all or a portion of theneck of the aneurysm, thereby preventing egress of the implant into theparent vessel, and also disrupting the flow of blood into the aneurysm.Even if a single broad region covers only a portion of the aneurysmneck, a plurality of broad regions near the neck collectively providecomplete or near complete neck coverage. In other embodiments, the mesh101 can be configured to have other flat, broad, or layeredconfigurations.

The broad portions 110 can have the same general characteristics, suchas size, curvature and/or shape, along the longitudinal dimension L, orthe characteristics of the broad portions 110 can vary along thelongitudinal dimension L. For example, in the embodiment shown in FIG.1B, the broad portions 110 include a plurality of first broad portions116 having a first size and a plurality of second broad portions 117having a second size smaller than the first size. Additionally, each ofthe broad portions 110 has a generally concave shape that defines agenerally constant radius of curvature, and in a particular embodiment,one or more of the broad portions 110 can have different radii ofcurvature. To illustrate this feature, FIG. 1C is a cross-sectionalrepresentation of two broad portions 110 of the occlusion device 100taken along lines 1C.1-1C.1 and 1C.2-1C.2, respectively, in FIG. 1B,that schematically shows the relative radial positioning of the broadportions in the unconstrained, deployed configuration shown in FIG. 1A.Also, the first and second broad portions 116 and 117 are shown opposedto each other for ease of illustration with the understanding that inpractice these broad portions may overlap or have differentcircumferential positions. In this example, the first broad portions 116individually have a first radius of curvature R₁ and the second broadportions 117 individually have a second radius of curvature R₂ less thanthe first radius of curvature R₁. As demonstrated by FIG. 1C, each ofthe first broad portions 116 has an inner surface 116 a that defines aportion of the circumference of a circle C₁ having a first radius R₁,and each of the second broad portions 117 has an inner surface 117 athat defines a portion of the circumference of a circle C₂ having asecond radius R₂ less than the first radius R₁.

Referring to FIGS. 1A and 1B, the plurality of first broad portions 116in this embodiment are positioned along the longitudinal dimension Ldistal of the plurality of second broad portions 117. As such, thelarger first broad portions 116 are delivered to the aneurysm first andform an outer mesh structure configured to contact and conform to aninner surface of the aneurysm. As shown in FIG. 1A, the outer meshstructure defines an interior region 118, and the smaller second broadportions 117 are deployed within the interior region 118 to form aninner mesh structure nested within the outer mesh structure. In theembodiment shown in FIGS. 1A-1C, each of the outer mesh structure andthe inner mesh structure is generally spherical. In other embodiments,one or both of the outer mesh structure and the inner mesh structure canhave other suitable shapes. In yet other embodiments, one or moreportions of the mesh 101 are not heat set to form a predeterminedthree-dimensional shape (independently or collectively).

In the embodiment shown in FIGS. 1A-1C, the mesh 101 is formed of atubular braid that has been heat set after being wrapped around a seriesof spherical molds. For example, in one method of manufacture inaccordance with the present technology, a first portion of the tubularbraid is wrapped one or more times around all or a portion of a firstspherical mold having a first diameter. The portion of the braid wrappedaround the first spherical mold forms the smaller second broad portions117 of the inner mesh structure. As the tubular braid is wrapped aroundthe spherical mold, opposing portions of the tubular sidewall arepressed toward one another along the length of the tubular braid,thereby “flattening” the tubular braid while conforming the braid to thecurvature of the spherical mold. For example, the cross-sections of themesh 101 shown in FIG. 1C schematically illustrate the flattenedopposing portions 111 a, 111 b of the sidewall 111 of the once-tubularbraid. The resulting broad portion 110 has lateral edges 119, an outerconvex braided layer 111 a, and an inner concave braided layer 111 bthat contacts the outer layer 111 a along all or a portion of theirrespective lengths. The outer layer 111 a and the inner layer 111 b meetat the lateral edges 119. To form a broad portion 110 having a desiredarc length between the lateral edges 119, the braid can be flattenedagainst the first spherical mold such that the lateral edges 119 span aparticular width of the spherical mold. The braid can be wrapped 180degrees around the first spherical mold any number of times to achieve adesired number of smaller second broad portions 117. Between wraps, thebraid can be pinched together (e.g., via a temporary tubular band,clamp, or other methods) to form the narrow portions 122 (FIGS. 1A and1B). In the embodiment shown in FIGS. 1A-1C, the mesh 101 has foursmaller second broad portions 117. In other embodiments, the mesh 101can have more or fewer smaller second broad portions 117.

To form the larger broad portions 116 of the outer mesh structure, asecond hollow spherical mold having a second diameter greater than thefirst diameter is placed over the first spherical mold, thereby trappingthe first portion of the braid that has been wrapped around the firstspherical mold between an outer surface of the first spherical mold andan inner surface of the second spherical mold. A second portion of thetubular braid is fed through an opening in the second spherical mold,and the second portion of the tubular braid is wrapped around the secondspherical mold in a similar manner as the first portion. In theembodiment shown in FIGS. 1A-1C, the mesh 101 has three larger firstbroad portions 116. In other embodiments, the mesh 101 can have more orfewer larger first broad portions 116. A mesh fixture is then positionedover the assembly, and the assembly is heat set. Although the mesh 101shown in FIGS. 1A-1C is configured to form two spherical layers (e.g.,the outer mesh structure and the inner mesh structure), in otherembodiments, the mesh 101 can be configured to form more or fewerlayers. For example, one or more additional molds can be used to formadditional mesh structures from a remaining portion of the tubularbraid.

The braid is formed of a plurality of metallic wires, and at least aportion of the wires can have a radiopaque core (e.g., platinum)surrounded by a shape memory alloy and/or superelastic alloy (e.g.,nitinol). In these and other embodiments, at least a portion of thewires can be made of other suitable materials.

In some embodiments, the stiffness of the occlusion device 100 variesalong its longitudinal dimension L. For example, the stiffness of one ormore portions of the mesh 101 is different than other portions of themesh 101 by varying one or more parameters such as the materials,porosity, thickness, braid count (if applicable), and braid pitch (ifapplicable) in the individual portions. The stiffness of one broadportion 110 is different from that of another broad portion 110. Forexample, for the mesh 101 shown in FIGS. 1A-1C, it may be desirable forthe larger first broad portions 116 comprising the outer mesh structureto have a first stiffness for framing the aneurysm, and the smallersecond broad portions 117 comprising the inner mesh structure to have asecond stiffness less than the first stiffness so that the smallersecond broad portions 117 are more flexible than the larger first broadportions 116 for packing the aneurysm. Moreover, it may be desirable forthe larger first broad portions 116 to be relatively stiffer than themore proximal second broad portions 117 since, once the occlusion device100 is positioned within the aneurysm, the stiffness will enhance theanchoring and structural integrity of the first broad portions 116 thatspan across at least a portion of the neck of the aneurysm.

To enhance visibility of the occlusion device 100 and/or mesh 101 duringdelivery to the aneurysm and/or subsequent to implantation within theaneurysm, the embodiment of the occlusion device 100 shown in FIGS. 1Aand 1B optionally includes a flexible member 113, such as a radiopaqueelement (e.g., a platinum coil), that extends along and/or within atleast a portion of the length of the mesh 101. The proximal and distalends of the flexible member 113 is coupled to the proximal and distalend portions 107, 109, respectively, of the mesh 101 and/or the proximaland distal connectors, 105, 103, respectively (e.g., directly or via asuture). In other embodiments, only one end of the flexible member 113is connected to one of the proximal connector 105 or the distalconnector 103.

Referring still to embodiment shown in FIGS. 1A and 1B, the intermediateportion 106 of the occlusion device 100 has a preset shape that orientsthe distal portion 108 of the occlusion device 100 at a predeterminedangle with respect to the proximal portion 104 upon deployment toprevent the distal portion 108 from. The intermediate portion 106comprises a radially compacted, curved or bent portion of the mesh 101that connects a distal-most broad portion 120 to the distal portion 108of the occlusion device 100. In other embodiments, the intermediateportion 106 can be a separate component coupled to the mesh 101 and/orthe proximal portion 104, and/or the intermediate portion 106 can haveother suitable shapes and/or configurations (some of which are detailedbelow with reference to FIGS. 6-12).

The distal portion 108 of the embodiment of the occlusion device 100shown in FIGS. 1A and 1B includes a directing region 122, and thelead-in member 102 extends distally from the directing region 122. Thedirecting region 122 has a proximal terminus 122 a and a distal terminus122 b (FIG. 1A). The directing region 122 extends distally from theintermediate portion 106 along the longitudinal axis L of the occlusiondevice 100 and, as such, a proximal terminus of the distal portion 108corresponds to the proximal terminus 122 a of the directing region 122.The directing region 122 shown in FIGS. 1A and 1B has an elongated,generally straight configuration and includes a distal zone 124 of themesh 101 and the connector 103. In this particular embodiment, thedistal zone 124 of the mesh 101 has a radially compacted, substantiallycylindrical shape. In other embodiments, the directing region 122 and/orthe distal zone 124 can have other suitable shapes, sizes, and/orconfigurations, such as those shown in FIGS. 6-12. The directing region122 does not need to include any portion of the mesh 101, but insteadcan be a separate component coupled to the intermediate portion 106.Additionally, the proximal and distal connectors 105, 103 can be madeof, include, and/or be coated with a radiopaque material to enhancevisibility of the occlusion device 100.

As shown in FIGS. 1A and 1B, this embodiment of the lead-in member 102has a curved shape in a deployed configuration For example, the lead-inmember 102 initially extends distally with respect to the directingregion 122 (e.g., from the connector 103) then curves proximally towardthe directing region 122 until terminating at an atraumatic tip 126.Because the lead-in member 102 is the first portion of the occlusiondevice 100 that exits the delivery catheter and contacts the aneurysmwall, the atraumatic tip and/or curved shape of the lead-in member 102reduces or eliminates stress on the aneurysm wall when delivering theocclusion device 100 to the aneurysm sac. The lead-in member 102 doesnot necessarily need to be curved as shown, but can be generallystraight and/or have other atraumatic yet sufficiently resilientconfigurations. In the embodiment shown in FIGS. 1A and 1B, the lead-inmember 102 is a separate, coiled tube (e.g., a radiopaque coil) that iscoupled to the connector 103. In other embodiments, the lead-in member102 can be formed integrally or monolithically with the occlusion device100. For example, in some embodiments, the elongated member 113 canextend beyond the distal terminus of the mesh 101 and/or connector 103to form the lead-in member 102. In yet other embodiments, the occlusiondevice 100 does not include a lead-in member 102 and the distal portion108 is comprised solely of the directing region 122.

2.0 Representative Embodiments

FIG. 2 is a side view of the occlusion device 100 of FIGS. 1A and 1B,shown in a partially-deployed configuration after the distal portion 108and intermediate portion 106 have exited a delivery catheter 200. Asshown in FIG. 2, the directing region 122 extends along a firstdirection A1 that runs through its proximal terminus 122 a and itsdistal terminus 122 b. In some embodiments, the proximal terminus 122 aand the distal terminus 122 b can refer to a correspondingcross-sectional area of the directing region 122, and the firstdirection A1 can be defined by a straight line extending through acenter of each cross-sectional area. The proximal portion 104 extendsalong a second direction A2 for the portion of its length immediatelyproximate the intermediate portion 106. For example, a medially locatedpath along a longitudinal direction of the distal-most broad portion 120can define the second direction A2.

As shown in FIG. 2, the intermediate portion 106 can be configured suchthat the first direction A1 of the directing region 122 extends at anangle θ with respect to the second direction A2 of the proximal portion104 when the occlusion device 100 is in a deployed configuration. Theangle θ is between about 45 degrees and about 135 degrees, or betweenabout 60 degrees and about 120 degrees (e.g., 65 degrees, 66 degrees, 70degrees, 75 degrees, 78 degrees, 82 degrees, 84 degrees, 90 degrees, 95degrees, 98 degrees, 105 degrees, 107 degrees, 115 degrees, etc.). Inparticular embodiments, the angle θ is between about 80 degrees andabout 110 degrees, and in some embodiments, between about 85 degrees andabout 105 degrees. As detailed below with reference to FIGS. 4A-5, whenthe angle θ is between about 45 degrees and about 135 degrees, itenables pushing the occlusion device 100 out of the delivery catheter200 and/or re-sheathing the occlusion device 100 while preventing, or atleast inhibiting, the distal portion 108 from exiting the aneurysmthrough the neck during deployment. By preventing or at least inhibitingthe distal portion from passing through the neck during deployment, thewhole occlusion device 100 is deployed within the aneurysm such that noportion of the occlusion device 100 protrudes into the parent vessel. Assuch, in contrast to traditional embolic coils and/or intracranialstents, the occlusion device 100 of the present technology significantlyreduces and/or the eliminates the presence of any nidus in the parentvessel that could be the site for the formation of a thromboembolism.

In addition to the angle θ, the length of the directing region 122(measured along the first direction A1 between its proximal terminus 122a and its distal terminus 122 b) is a design factor related todeployment of the occlusion device 100. For example, if the length ofthe directing region 122 is too short, the directing region 122 cancatch on the distal end of the delivery catheter 200. If the length ofthe directing region 122 is too long, the distal portion 108 is morelikely to exit the aneurysm through the neck, especially in shallowaneurysms. The directing region 122 generally has a length that is fromabout 25% and about 75% of the aneurysm diameter. For example, thelength is from about 0.005 inches and about 0.25 inches, and in someembodiments, from about 0.05 inches and about 0.20 inches. Morespecifically, the length is between about 0.09 inches and about 0.20inches, or from about 0.09 inches and about 0.18 inches. The length ofthe directing region 122, however, is a function of several factors andis not necessarily limited to being within the above ranges.

FIGS. 3A and 3B are top and side views of the occlusion device 100 ofFIGS. 1A-2 in a partially-deployed configuration once the distal portion108, intermediate portion 106, and distal-most broad portion 120 haveexited the delivery catheter 300 (only shown in FIG. 3A). In itsdeployed configuration, the intermediate portion 106 positions thedistal portion 108 of the occlusion device 100 generally within the sameplane P (FIG. 3B) as the distal region of the distal-most broad portion120 of the mesh 101 (FIGS. 1A and 1B). As such, during delivery of theocclusion device 100 to a target aneurysm, the distal portion 108 slidesalong the inner surface of the aneurysm while the proximal portion 104is pushed out of the delivery catheter 300 to fill the aneurysm.

FIGS. 4A-4E illustrate a method of positioning the occlusion device 100within an aneurysm A having a neck N open to a blood vessel V inaccordance with an embodiment of the present technology. The occlusiondevice 100 is intravascularly delivered to a location within a bloodvessel lumen L adjacent a target aneurysm A in a low-profileconfiguration (not shown) within a delivery catheter 400. The distalportion of the delivery catheter 400 is then advanced through the neck Nof the aneurysm A to an interior region of the aneurysm A. As shown inFIG. 4A, the occlusion device 100 is then deployed by pushing theocclusion device 100 distally through the distal opening of the deliverycatheter 400 towards a wall of the aneurysm A. As the distal portion 108and intermediate portion 106 exit the delivery catheter 400, theintermediate portion 106 moves into a pre-set curved shape to positionthe directing region 122 at a predetermined angle with respect to theemerging proximal portion, as well as with respect to an axis of thedistal end region of the delivery catheter 400.

Referring to FIGS. 4B-4D, as more of the occlusion device 100 exits thedelivery catheter 400, the distal portion 108 contacts the aneurysm walland slides up and around the curved inner surface of the aneurysm A.FIG. 4E shows the distal portion 108 as it reaches the neck N of theaneurysm. At this point of deployment, the angle of the directing region122 with respect to the proximal portion 104 directs the distal portion108 away from exiting the aneurysm A through the neck N, and insteadguides the distal portion 108 across the neck N of the aneurysm A. Asshown in FIG. 4E, the combination of the preset angle θ between thedirecting region 122 and the proximal portion 104 and the length of thedirecting region 122 relative to a diameter of the aneurysm A enablesthe directing region 122 to direct the distal portion 108 as theocclusion device 100 is being pushed distally out of the deliverycatheter 400 into the aneurysm A. As such, the directing region 122inhibits the distal portion 108 from exiting the aneurysm A through theneck N and instead directs the proximal portion 104 to cross the neck Nand generally remain within the aneurysm A.

To better appreciate the operation of the directing region 122 of thepresent technology, FIG. 5 shows a hypothetical occlusion device 100′with a region 122′ where the angle β can allow a portion of thehypothetical device 100′ to extend into the aneurysm A. As shown in theFIG. 5, the hypothetical occlusion device 100′ is not configured inaccordance with the present technology (and included for illustrativepurposes only) because the angle between the region 122′ and thedistal-most broad portion is too large such that the distal portion willslide along the inner surface of the aneurysm A and, upon reaching theneck N, exit the aneurysm A into the blood vessel lumen L.

3.0 Additional Embodiments

FIGS. 6-12 shows portions of several embodiments of occlusion devicesconfigured in accordance with the present technology. FIG. 6, forexample, shows a portion of one embodiment of an occlusion device 600having a distal portion 608 that does not include a lead-in member suchthat a directing region 622 comprises the entire distal portion 608.FIG. 7 shows a portion of another embodiment of an occlusion device 700that, like the occlusion device 600 shown in FIG. 6, does not include alead-in member. Additionally, the occlusion device 700 has anintermediate portion 706 and a directing region 722 that are formed asingle, continuous non-mesh component (e.g., a tube or solid member).

FIG. 8 illustrates a portion of an occlusion device 800 configured inaccordance with a further embodiment of the present technology. Theocclusion device 800, like the occlusion device 600 shown in FIG. 6,does not include a lead-in member. The occlusion device 800 of FIG. 8has an intermediate portion 806 defined by a mesh structure, and adirecting region 822 comprising a generally cylindrical componentcoupled to the mesh structure at the intermediate portion 806.

A portion of an occlusion device 900 configured in accordance with yetanother embodiment of the present technology is shown in FIG. 9. Theocclusion device 900 includes an intermediate portion 906 and adirecting region 922 extending from the intermediate portion. Theintermediate portion 906 is a curved, non-mesh component. The directingregion 922 includes a radially compacted, elongated mesh that terminatesat a distal crimp. The occlusion device 900 does not include a lead-inmember. As such, a distal terminus of the directing region 922 comprisesa distal terminus of the occlusion device 900.

FIGS. 10 and 11 show occlusion devices 1000 and 1100, respectively, thatare made entirely of a mesh structure. For example, in FIG. 10, theocclusion device 1000 has an intermediate portion 1006 and a directingregion 1022 formed of a continuous mesh structure. As shown in FIG. 10,the directing region 1022 can be defined by the distal-most portion ofthe mesh structure. The occlusion device 1000 of FIG. 10 does notinclude a lead-in member. The occlusion device 1100 of FIG. 11 alsoincludes an intermediate portion 1106 and a directing region 1122 formedof a single, continuous mesh structure, as well as a lead-in member 1102formed of a curved, distal-most portion of the mesh structure.

FIG. 12 illustrates a portion of an occlusion device 1200 configured inaccordance with a further embodiment of the present technology. In FIG.12, the occlusion device 1200 includes a non-linear directing region1222 having an axis A1 defined by a straight line between the proximaland distal termini of the directing region 1222. The occlusion device1200 includes an intermediate portion 1206 that positions the axis A1 ofthe directing region 1222 at about a right angle θ with respect to anaxis A2 of the proximal portion 1204 of the occlusion device 1200.

4.0 Additional Embodiments of Occlusion Devices for Use with theDirecting Regions Disclosed Herein

Any of the distal portions, intermediate portions, and/or directingregions disclosed herein can be used with additional occlusion devices.For example, the distal ends of any of the occlusion devices describedbelow with reference to FIGS. 13A-38 can be configured to include any ofthe intermediate portions (e.g., 106, 606, 706, 806, 906, 1006, 1106,etc.), distal portions (e.g., 108, 608, etc.), and/or directing regions(e.g., 122, 622, 722, 822, 922, 1022, 1122, 1222, etc.) disclosed abovewith reference to FIGS. 1A-12.

FIGS. 13A and 13B, for example, are schematic illustrations of a medicaldevice 1300 shown in a first configuration and a second configuration,respectively. The medical device 1300 is configured to promote healingof an aneurysm. More specifically, at least a portion of the medicaldevice 1300 is configured to occupy at least a portion of the volumedefined by a sac of the aneurysm and, in some embodiments, at least aportion of the medical device 1300 is configured to promote endothelialcell attachment over a neck of the aneurysm. Once endothelializationover the aneurysm neck is complete, blood flow into the aneurysm sacfrom a parent blood vessel (i.e., the vessel on which the aneurysmformed) is prevented.

The medical device 1300 can include an insertion portion 1302 and anocclusion device 1310. The insertion portion 1302 is coupled to theocclusion device 1310, such as, for example, at a proximal portion 1312of the occlusion device 1310. In some embodiments, the insertion portion102 is removably coupled to the occlusion device 1310. In this manner,the insertion portion 102 can be separated from the occlusion device1310 following delivery of the occlusion device to the aneurysm andremoved from a patient's vasculature. The insertion portion 1302 can be,for example, a guide wire or a distal end portion of a wire. The medicaldevice 1300 can be used with a cannula or catheter 1304 (shown in dashedlines in FIGS. 13A and 13B) to, for example, deliver the occlusiondevice 1310 to the aneurysm.

The occlusion device 1310 is configured to be deployed in the aneurysm(e.g., in a sac of an aneurysm). The occlusion device 1310 has a firstportion 1320 and a second portion 1330. As shown in FIG. 13A, theocclusion device 1310 has a first configuration in which the firstportion 1320 and the second portion 1330 are substantially linearlyaligned. In its first configuration, the occlusion device 1310 isconfigured for insertion through a blood vessel. The occlusion device1310 is also configured for insertion through a neck of the aneurysmwhen in its first configuration.

The occlusion device 1310 is movable between its first configuration anda second configuration in which the second portion 1330 at leastpartially overlaps the first portion 1320, as shown in FIG. 13B. Forexample, the second portion 1330 can be configured to bend, curve and/ortwist in multiple turns such that multiple segments of the first portion1320 and the second portion 1330 are overlapped. Additionally, at leastone of the first portion 1320 and the second portion 1330 can beconfigured to bend or curve in multiple turns such that the respectivefirst or second portion is overlapped with itself. In some embodiments,the occlusion device 1310 can be understood to have multiple firstportions and multiple second portions. In other words, the occlusiondevice can continually overlap itself in its deployed configuration tooccupy all or substantially all of the volume of the aneurysm.

In its second configuration, the occlusion device 1310 is configured tooccupy at least a portion of the volume defined by the sac of theaneurysm. In some embodiments, when the occlusion device 1310 is in itssecond configuration, at least a portion of the occlusion device isconfigured to be positioned over the neck of the aneurysm. For example,the portion of the occlusion device 1310 at which the second portion1330 overlaps the first portion 1320 can be configured to be positionedover the neck of the aneurysm. As such, the portion of the occlusiondevice 1310 disposed over the aneurysm neck has an increased density(e.g., a dual density compared to the first portion 120 or the secondportion 1330 individually), which helps to limit or prevent blood flowfrom entering the sac of the aneurysm. The portion of the occlusiondevice 1310 positioned over the aneurysm neck can be a scaffold forendothelial cell attachment at the aneurysm neck. For example, theportion of the occlusion device 1310 positionable over the aneurysm neckcan be porous, such as by including a porous mesh, as described in moredetail herein. In some embodiments, the first portion 1320 and thesecond portion 1330 of the occlusion device 1310 are biased to thesecond configuration.

As noted above, in some embodiments, at least a portion of the occlusiondevice 1310 is porous. For example, in some embodiments, at least aportion of the occlusion device 1310 can include and/or be constructedof a mesh (e.g., woven, braided, or laser-cut) material such that a wallor layer of the occlusion device 1310 defines multiple openings orinterstices 1318. More specifically, in some embodiments, at least oneof or both the first portion 1320 and the second portion 1330 of theocclusion device 1310 can include the porous mesh. The porous mesh canhave a first porosity when the occlusion device 1310 is in its firstconfiguration and a second porosity when the occlusion device is in itssecond configuration. More specifically, in some embodiments, the porousmesh can have a greater porosity when the occlusion device 1310 is inits second configuration than when the occlusion device is in its firstconfiguration. The porosity of the porous mesh can be increased, forexample, because one or more individual pores or openings are largerwhen in the second configuration than in the first configuration. Forexample, the porous mesh can be expanded in the second configuration,thereby increasing the space between filaments of the mesh (and thus thesize of one or more openings of the mesh). In other words, an overallvolume of pore openings can be increased. In another example, theporosity of the porous mesh can be increased because one or moreopenings that were closed off when the occlusion device 1310 wascollapsed into its first configuration are reopened when the occlusiondevice is moved to its second configuration. In other words, a number ofopen pores can be increased.

In some embodiments, the first portion 1320 and the second portion 1330can have one of the same or different porosities. For example, the firstportion 1320 can have a porosity greater than a porosity of the secondportion 1330. in another example, the second portion 1330 can have aporosity greater than the porosity of the first portion 1320. In stillanother example, the first and second portions 1320, 1330 can havesubstantially equivalent porosities in the expanded configuration.

In some embodiments, at least one of the first portion 120 and thesecond portion 130 includes one, two, three, or more layers. Forexample, in some embodiments, the first portion 120 of the occlusiondevice 1310 includes a first layer (not shown in FIG. 13A or 13B) ofporous mesh and a second layer (not shown in FIG. 13A or 13B) of porousmesh. The first layer and the second layer can have the same ordifferent porosities. In some embodiments, the first layer is offsetfrom the second layer. As such, the porosity of the first portion isdetermined by the porosities of the first and second layers and themanner in which the first layer is offset from the second layer.

In some embodiments, at least a portion of the occlusion device 1310,such as at least one of the first portion 1320 or the second portion1330 can include a shape-memory material, such as, for example, nitinol,and can be pre-formed to assume a desired shape. Thus, in such anembodiment, the portion of the occlusion device 1310 (e.g., the firstportion 1320 and/or the second portion 1330) can be biased into anexpanded second configuration and moved to a collapsed firstconfiguration by restraining or compressing the portion of the occlusiondevice.

In some embodiments, at least a portion of the occlusion device 1310,such as at least one of the first portion 1320 or the second portion1330 can include an electropositive material, described in more detailbelow.

The occlusion device 1310 when in the expanded configuration can have avariety of different shapes, sizes and configurations. For example, insome embodiments, when in the expanded configuration the occlusiondevice 1310 can be substantially spherical. In some embodiments, theocclusion device 1310 can be substantially helical. In some embodiments,the occlusion device 1310 can be substantially circular, disc-shaped, orring-shaped. In some embodiments, the occlusion device 1310 can be acustom-made shape based on a shape of a target aneurysm within apatient: for example, a shape modeled after the shape of the targetaneurysm as detected by an imaging device. For example, an image of theaneurysm shape can be acquired using an angiogram, and the occlusiondevice 1310 can be modeled after the shape of the aneurysm shown in theangiogram. In some embodiments, the occlusion device 1310 can includemultiple portions having varying outer perimeters or outer diameters.For example, in some embodiments, when in the expanded configuration theocclusion device 1310 can include a first portion having a first outerperimeter, a second portion having a second outer perimeter and a thirdportion having a third outer perimeter. In such an embodiment, thesecond outer perimeter can be smaller than each of the first outerperimeter and the third outer perimeter.

In one example use of the medical device 100, a catheter 1304 can beinserted into a blood vessel and directed to a desired treatment sitenear a vascular defect, such as the aneurysm. The occlusion device 1310is inserted into an elongate lumen of the catheter 1304 for delivery tothe treatment site. A distal portion of the catheter 1304 is positionedadjacent the aneurysm within the blood vessel. The occlusion device 1310is moved from a first position inside the catheter to a second positionoutside the catheter. When the occlusion device 1310 is in its firstposition, each of the first portion 1320 and the second portion 1330 arein a first configuration. For example, in the first configuration, eachof the first and second portions 1320, 1330 can be compressed orcollapsed within the lumen of the catheter 1304 and are substantiallylinear in configuration.

The occlusion device 1310 can be oriented with respect to an opening inthe vessel wall in fluid communication with the aneurysm such that theocclusion device can enter a sac of the aneurysm when the occlusiondevice 1310 is moved to its second position. The occlusion device 1310can be moved from its first position to its second position with theassistance of the insertion portion 1302 such that the occlusion device1310 is directed into and positioned within a sac of the aneurysm. Whenthe occlusion device 1310 is in its second position, the first andsecond portions each have a second configuration. For example, in thesecond configuration, each of the first and second portions 1320, 1330can be expanded into a three-dimensional shape. The three-dimensionalshape of the first portion 1320 in the second configuration can besimilar to or different from the three-dimensional shape of the secondportion 1330. In the second configuration, the first portion 1320 of theocclusion device 1310 substantially overlaps the second portion 1330. Insome embodiments, the second portion 1330 is disposed in an interiorregion defined by the first portion when each of the first portion andthe second portion are in their respective second configurations.

The first and second portions 1320, 1330 can be moved to theirrespective second configurations concurrently or sequentially. Forexample, in some embodiments, the second portion 1330 is moved to itssecond configuration before the first portion 1320 is moved to itssecond configuration. The occlusion device 1310 can assume a biasedexpandable configuration such that the walls of the occlusion device1310 contact at least a portion of the wall of the aneurysm and/or suchthat a portion of the occlusion device is disposed over the neck of theaneurysm. The presence of the occlusion device 1310 over the neck of theaneurysm can substantially reduce and/or prevent further blood flow fromthe parent vessel into the aneurysm sac because the occlusion device canact as a physical flow disruptor for blood flowing from the parentvessel and as a scaffold for endothelial cell attachment at the aneurysmneck to promote endothelialization of the neck/vessel wall. Theinsertion portion 1302 can then be disconnected from a proximal end ofthe occlusion device 1310 and removed through the catheter 1304.

FIGS. 14A-14E illustrate a medical device according to an embodiment.The medical device 1400 can include all or some of the same features andfunctions as described above for medical device 1300. The medical device1400 includes an insertion portion 1402 and an occlusion device 1410.The occlusion device 1410 is removably coupled at its proximal end to adistal end of the insertion portion 1402.

The occlusion device 1410 includes a first portion 1420 and a secondportion 1430. As shown in FIGS. 14A and 14C, the occlusion device 1410has a first, or collapsed, configuration in which the first and secondportions 1420, 1430 are substantially linearly aligned. In this manner,the occlusion device 1410 can be disposed within a lumen of a catheter1404 for delivery through a blood vessel V to a treatment site, such asto an aneurysm A. In its first configuration, the occlusion device 1410has a first width W1, as shown in FIG. 14A. As shown in FIGS. 14B, 14D,and 14E, the occlusion device 1410 is moveable to a second, or expandedor deployed, configuration. The insertion portion 1402 is configured tomove the occlusion device 1410 from the first configuration to thesecond configuration. The insertion portion 1402 can be disconnectedfrom the occlusion device 1410 when the occlusion device 1410 is in itssecond configuration.

In its second configuration, the occlusion device 1410 is configured tooccupy at least a portion of the volume defined by a sac of the aneurysmA. As such, the occlusion device 1410 has a second width W2 in thesecond, expanded, configuration greater than its first width W1. Forexample, the occlusion device 1410 can be substantially narrow andelongate in its first configuration and can assume a three-dimensionalshape in its second configuration. In the embodiments illustrated inFIGS. 14A-14E, the occlusion device 1410 has a substantially sphericalshape in its second configuration. The occlusion device 1410 can becompliant such that its three-dimensional shape can accommodate anyirregularities in the shape of the aneurysm. In the secondconfiguration, the second portion 1430 of the occlusion device 1410 atleast partially overlaps the first portion 1420. At least a portion ofthe occlusion device 1410 is configured to be positioned over a neck Nof the aneurysm A when the occlusion device is in its secondconfiguration within the sac of aneurysm A. The occlusion device 1410 isconfigured to facilitate endothelial cell attachment at the neck N ofthe aneurysm A, as described in more detail herein.

In the embodiment illustrated in FIG. 14A, the first portion (or member)1420 is a first ribbon-like strand and the second portion (or member)1430 is a second ribbon-like strand discrete from the first portion. Inother embodiments, an occlusion device can include a first portion and asecond portion from a single ribbon-like strand (e.g., integrally ormonolithically constructed), instead of discrete portions. A first end1422 of the first portion 1420 is coupled to a first end 1432 of thesecond portion 1430. Any suitable mechanism for coupling the first end1422 of the first portion 1420 to the first end 232 of the secondportion 1430 can be used, such as an adhesive, a mechanical coupler, aweld, or the like, or any combination of the foregoing. For example, thefirst ends 1422, 1432 can be coupled by a band 1440. The band 1440 canalso be configured to help couple the insertion portion 1402 to theocclusion device 1410. The band 1440 can be or can include, for example,a radiopaque marker.

A second end 1424 of the first portion 1420 and a second end 1434 of thesecond portion 1430 each have a radiopaque marker 1442, 1444,respectively, coupled thereto. The radiopaque markers 1442, 1444 areconfigured to facilitate imaging of the occlusion device 1410 duringdelivery to the treatment site and/or subsequent to implantation. Themarkers 1442, 1444 are configured to be wholly disposed within the sacof the aneurysm A when the occlusion device 1410 is in its secondconfiguration. As such, the markers 1442, 1444 will not puncture thewall of the aneurysm A or the vessel V, and the markers 1442, 1444 willnot interfere with endothelial cell attachment at the aneurysm neck.This is also beneficial because if the markers 1442, 1444 werepositioned at or proximate to the neck of the aneurysm, blood from aparent blood vessel could have a tendency to clot around the marker.

When the expandable member 1410 is moved between its first configurationand its second configuration, at least one of the first portion 1420 andthe second portion 1430 is also moveable between a first configurationand a second configuration. The first portion or member 1420 has afirst, collapsed, configuration in which the first portion 1420 issubstantially elongate and has a first width. The first portion 1420 hasa second, expanded, configuration, in which the first portion 1420 has asecond width greater than the first width. For example, the firstportion 1420 can be moveable from a substantially linear, elongatecollapsed configuration to a multi-dimensional (e.g., three-dimensional)shape in the expanded or deployed configuration. As shown in FIGS. 14Band 14E, the first portion 1420 can have a three-dimensional shape inthe expanded configuration that lends an overall spherical shape to theocclusion device 1410. The first portion 1420 can be biased to itssecond, expanded, configuration.

The first portion or member 1420 is porous and, for example, can includeor be constructed of a porous mesh. The porous mesh can be formed usingfilaments that are woven or braided together in a manner that openingsor interstices are present between portions of the filaments at leastwhen the occlusion device 1410 is in its second configuration. Forexample, the porous mesh can include a plurality of braided wires.Suitable mesh material is described in more detail herein. The porousmesh can have a first porosity when the first portion 1420 is in thefirst configuration and a second porosity when the first portion 1420 isin the second configuration. For example, when the first portion 1420 ismoved from its first, collapsed, configuration to its second, expanded,configuration, the mesh can be expanded such that the size of theopenings of the mesh is increased, thus increasing the porosity of themesh. The porous mesh is configured to act as a scaffold that promotesclot formation and endothelium cell attachment when the mesh is disposedwithin the aneurysm A. Specifically, endothelial cells will migrate tothe openings of the mesh.

The first portion 1420 of the occlusion device 1410 includes a firstlayer of porous mesh and a second layer of porous mesh. In this manner,the density of the first portion 1420 is greater than the density ofeither the first or second layers individually. Such a dual-densitystructure can help to limit or prevent blood flow into the aneurysm A,for example when the first and second layers of the first portion 1420arc disposed over the neck N of the aneurysm A. The first layer ofporous mesh and the second layer of porous mesh can have the sameporosities, or different porosities. The first layer of porous mesh canbe offset from the second layer of porous mesh. In this manner, theoverall porosity of the first portion 1420 is greater than the porosityof either the first or second layers individually. The first and secondlayers of porous mesh can be coupled together in any suitable manner.For example, the first portion 1420 can be formed using an elongatetubular mesh having an elongate lumen therethrough. In such anembodiment, the elongate mesh can be flattened from a tubular structureto a ribbon-like structure such that a first side, or layer, of the meshis disposed on or proximate to a second side, or layer, of the mesh,thus forming a dual density, or dual-layered, mesh structure.

The second portion, or member, 1430 of the occlusion device 1410 can beconfigured the same as or similar to, and can be used in the same orsimilar manner, as the first portion 1420. When the expandable member1410 is moved between its first configuration and its secondconfiguration, the second portion 1430 is also moveable between a first,collapsed, configuration in which the second portion is substantiallyelongate and has a third width, and a second, expanded, configuration,in which the second member has a fourth width greater than the thirdwidth. For example, the second portion 1430 can be moveable from asubstantially linear, elongate collapsed configuration to amulti-dimensional (e.g., three-dimensional) shape in the expandedconfiguration. As shown in FIGS. 14B and 14E, the second portion 1430can have a three-dimensional shape in the expanded configuration thatlends an overall spherical shape to the occlusion device 1410. Thesecond portion 1430 can be biased to its second, expanded,configuration.

The second portion 1430 is porous and can include or be constructed of aporous mesh. The porous mesh can be configured the same as or similarto, and can be used in the same or similar manner, as the porous meshdescribed above with respect to the first portion 1420 of the occlusiondevice 1410. For example, the porous mesh can include a weave or braidof filaments that is porous at least when the occlusion device 1410 isin its second configuration. Additionally, the porous mesh of the secondportion 1430 can have a first porosity when the second portion 1430 isin the first configuration and a second porosity when the second portion1430 is in the second configuration. In some embodiments, the secondportion 1430 of the occlusion device 1410 includes a first layer ofporous mesh and a second layer of porous mesh, which can be of the sameor different porosities. In this manner, the total density of the secondportion 1430 is greater than the density of either the first or secondlayers individually. The first layer of porous mesh can be offset fromthe second layer of porous mesh such that the overall porosity of thesecond portion 1430 is greater than the porosity of either the first orsecond layers individually. Similarly as described above with respect tothe first portion 1420, the first and second layers of porous mesh ofthe second portion 1430 can be formed from a monolithically constructedelongate tubular mesh that is flattened into a ribbon-like structure.

The first portion 1420 and the second portion 1430 of the occlusiondevice 1410 can be the same or different sizes. For example, as shown inFIG. 14E, the first portion 1420 can have a length in its first,collapsed, configuration, that is less than a length of the secondportion 1430 in its first, collapsed, configuration. In this manner, themarkers 242, 1444 will be sequentially introduced through the neck N ofthe aneurysm A, which permits the occlusion device 1410 to be introducedthrough a narrower neck N. In another example, the first portion 1420and the second portion 1430 can have the same or different widths. Insome embodiments, for example, the first width of the first portion 1420in its first configuration is wider than the third width of the secondportion 1430 in its first configuration. The second width of the firstportion 1420 in its second configuration can also be wider than thefourth width of the second portion 1430 in its second configuration. Inanother example, the fourth, expanded, width of the second portion 1430can be greater than the second, expanded, width of the first portion1420. In some embodiments, the porous mesh of the first portion 1420 canhave a multi-dimensional shape with a first width when the occlusiondevice 1410 is in its second configuration, and the porous mesh of thesecond portion 1430 can have a multi-dimensional shape with a secondwidth less than the first width when the occlusion device is in itssecond configuration.

In some embodiments, for example, the first portion 1420 (or the porousmesh of the first portion) can have a width of about 8 mm when theocclusion device is expanded in its second configuration, and the secondportion 1430 (or the porous mesh of the second portion) can have a widthof about 9.5 mm when the occlusion device is expanded in its secondconfiguration. As such, in an embodiment in which the first portion 1420has a smaller overall size in the expanded configuration than the secondportion 1430, the first portion 1420 can be configured to be disposedwithin an open interior region formed by the second portion 1430 in itssecond configuration.

In some embodiments, a variation of medical device 1400 is contemplated.For example, in such an embodiment, the first portion of the occlusiondevice can include a first tubular mesh that defines a lumentherethrough, and the second portion of the occlusion device can includea second tubular mesh disposed within the lumen of the first tubularmesh. The first and second tubular mesh structures can be formed into asubstantially ribbon-like strand. As such, the occlusion device has afour-layer density. The occlusion device can include additionalribbon-like strands in addition to the strand formed by the first andsecond portions. For example, the occlusion device can include one, two,three, four, five, six, seven, eight, or nine strands, with each of thestrands having a desired number of layers (e.g., two, four, or morelayers). As such, an occlusion device can be formed that has a desiredamount of density. As noted above, a highly dense structure helps toprevent blood flow from the parent blood vessel into the aneurysm. Eachlayer or portion of the occlusion device can have the same or differentdensity as the other layers or portions. Furthermore, each layer orportion of the occlusion device can have the same or different porosityas the other layers or portions.

FIG. 15 illustrates a portion of another embodiment of a medical device.The medical device 1500 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 1500 includes an occlusion device 1510 and an insertionportion or member (not shown in FIG. 15). The occlusion device 1510 isshown in an expanded configuration and can be moved between a compressedor collapsed configuration in which the occlusion device issubstantially elongate and the expanded configuration in the same orsimilar manner as described above for occlusion device 1410. In theexpanded configuration, a first portion 1520 of the occlusion device1510 is overlapped by a second portion 1530 of the occlusion device.Additionally, at least a portion of the first portion 1520 is disposedwithin an open interior region 1536 defined by the second portion 1530when the occlusion device 1510 is in its expanded configuration.

The occlusion device 1510 includes a ribbon-like strand of porous mesh.At least a portion of the porous mesh is configured to be positionedover a neck of an aneurysm when the occlusion device 1510 is in theexpanded configuration. The porous mesh is configured to bend, curve,and/or twist at multiple turns into a substantially spherical shape whenthe occlusion device 1510 is in the expanded configuration. The porousmesh can be a ribbon-like structure that is wider than the porous meshof occlusion device 1410. In this manner, the porous mesh of occlusiondevice 1510 can be a shorter length than that of occlusion device 1410and still provide a similar amount of coverage within the aneurysm (andover the neck of the aneurysm) as occlusion device 1410. The porous meshcan include one, two, or more layers depending on the desired densityand porosity of the occlusion device 1510. In some embodiments, a firstradiopaque marker 1542 is coupled to a first end 1512 of the occlusiondevice 1510 and a second radiopaque marker 1544 is coupled to a secondend 1514 of the occlusion device. The occlusion device 1510 isconfigured to be wholly disposed within the aneurysm such that theradiopaque markers 1542, 1544 are wholly disposed within the aneurysmsac and the porous mesh is disposed over the neck of the aneurysm. Insome embodiments, the radiopaque markers are configured to be positionedat a side of the aneurysm (i.e., disposed away from the neck of theaneurysm).

FIG. 16 illustrates another embodiment of a medical device. The medicaldevice 1600 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 1600 includes an occlusion device 1610 and an insertion portionor member 1602. The occlusion device 1610 is sized to occupy the sac ofan aneurysm, and the insertion member 1602 is configured to facilitatedelivery of the occlusion device into the sac of the aneurysm. Theocclusion device 1610 is shown in an expanded configuration and can bemoved between a compressed or collapsed configuration and the expandedconfiguration in the same or similar manner as described above forprevious embodiments.

The occlusion device 1610 includes at least one ribbon-like strand ofporous mesh configured to be expanded within the aneurysm as a 360degree spiral or ring-shaped structure. In the expanded configuration, afirst portion 1620 of the occlusion device 1610 is overlapped by asecond portion (not shown in FIG. 16) of the occlusion device, which isoverlapped by a third portion 1650 of the occlusion device. In thismanner, at least a portion of the occlusion device 1610 includes two,three, four, or more layers of implant material (e.g., porous mesh, asdescribed above in previous embodiments), which can be positioned overthe neck of the aneurysm from within the aneurysm to function as a denseflow disruptor. In some embodiments, a radiopaque marker 1642 is coupledto the occlusion device 1610.

FIG. 17 illustrates another embodiment of a medical device. The medicaldevice 1700 can include the same or similar features and functions asdescribed above for medical device 1600. For example, the medical device1700 includes an occlusion device 1710 and an insertion portion ormember 1702. The medical device 1700 can be delivered to an aneurysm orother vascular defect using a microcatheter 1704. The occlusion device1710 is sized to occupy at least a portion of the volume defined by thesac of the aneurysm, and the insertion member 1702 is configured tofacilitate delivery of the occlusion device into the sac of theaneurysm. The occlusion device 1710 is shown in an expandedconfiguration and can be moved between a compressed or collapsedconfiguration and the expanded configuration in the same or similarmanner as described above for previous embodiments.

The occlusion device 1710 includes a porous mesh configured to beexpanded within the aneurysm as a substantially circular or disc-shapedstructure, as shown in FIG. 17. In the expanded configuration, a firstend portion 1712 of the occlusion device 1710 is engaged with and/oroverlapped with a second end portion 1714 of the occlusion device. Theocclusion device 1710 includes a first portion 1720 having a firstdensity of porous mesh and a second portion 1730 having a second,higher, density of porous mesh. More specifically, a weave or braid ofthe porous mesh has a higher density in the second portion 1730 than inthe first portion 1720 of the occlusion device. The occlusion device1710 is configured to be disposed within the aneurysm (or other vasculardefect) such that at least a portion of the second portion 1730 isdisposed over the neck of the aneurysm, because the higher densitypromotes endothelial cell attachment to the occlusion device. Theocclusion device 1710 includes at least one radiopaque marker 1742,which can be disposed on one of the first end portion 1712 (as shown inFIG. 17) and/or the second end portion 1714. When the occlusion device1710 is disposed within the aneurysm in its expanded configuration suchthat the higher density second portion 1730 is disposed over the neck ofthe aneurysm, the at least one radiopaque marker 1742 is disposed withinthe sac of the aneurysm away from the neck of the aneurysm.

FIG. 18 illustrates another embodiment of a medical device. The medicaldevice 1800 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 1800 includes an occlusion device 1810 and an insertion portionor member 1802. The occlusion device 1810 is sized to occupy at least aportion of a volume defined by the sac of the aneurysm, and theinsertion member 1802 is configured to facilitate delivery of theocclusion device into the sac of the aneurysm. The occlusion device 1810is shown in an expanded configuration and can be moved between acompressed or collapsed configuration and the expanded configuration inthe same or similar manner as described above for previous embodiments.

The occlusion device 1810 includes a ribbon-like strand of porous meshhaving at least two layers of mesh. The occlusion device 1810 isconfigured to be expanded within the aneurysm as a substantially helicalor coil shaped structure, as shown in FIG. 18. The occlusion device 1810can be disposed within the aneurysm (or other vascular defect) such thatat least a portion of the implant is disposed over the neck of theaneurysm to facilitate endothelial cell attachment at the neck. Theocclusion device 1810 includes at least one radiopaque marker 1842,which can be disposed on an end of the occlusion device 1810, as shownin FIG. 18. The insertion member 1802 can be removably coupled to theocclusion device at the radiopaque marker.

FIG. 19 illustrates another embodiment of a medical device. A medicaldevice 1900 includes all the same or similar features and functions asdescribed above for medical device 1800. For example, the medical device1900 includes an occlusion device 1910, an insertion portion or member1902, and a radiopaque marker 1942 coupled to an end of the occlusiondevice. The occlusion device 1910 includes a porous mesh formed of atubular or rounded braid structure. The rounded braid structure can lendmore softness to the occlusion device 1910 than, for example, theflattened ribbon-like structure previously described.

FIG. 20 illustrates another embodiment of a medical device. The medicaldevice 2000 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 2000 includes an occlusion device 2010 and an insertion portionor member 2002. The medical device 2000 can be delivered to an aneurysmor other vascular defect using a microcatheter 2004. The occlusiondevice 2010 is sized to occupy at least a portion of the volume of thesac of the aneurysm, and the insertion member 2002 is configured tofacilitate delivery of the occlusion device from the microcatheter 2004into the sac of the aneurysm. The occlusion device 2010 is shown in anexpanded configuration and can be moved between a compressed orcollapsed configuration and the expanded configuration in the same orsimilar manner as described above for previous embodiments.

The occlusion device 2010 includes a first member 2020 and a secondmember 2030. The first and second members 2020, 2030 are coupled at afirst end 2012 of the occlusion device 2010 and a second end 2014 of theocclusion device. The first and second members 2020, 2030 are alsocoupled together at at least one middle portion of the occlusion device2010 between the first end 2012 and the second end 2014. The first andsecond members 2020, 2030 can be coupled, for example, using radiopaquemarkers 2042, 2044, 2046. Each site of coupling is configured to be afolding point of the occlusion device 2010 when the occlusion device isdelivered into the aneurysm and is expanded within the aneurysm tocomply with the shape of the aneurysm. As such, the occlusion device2010 can be more densely packed into the aneurysm, for example, ascompared to an implant that cannot bend or fold in response to the shapeof the aneurysm. At least one of the first member 2020 and the secondmember 2030 of the occlusion device 2010 includes a porous mesh formedof a tubular or rounded braid structure.

FIG. 21 illustrates another embodiment of a medical device. The medicaldevice 2100 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 2100 includes an occlusion device 2110 and an insertion portionor member 2102. The occlusion device 2110 is sized to occupy the sac ofthe aneurysm, and the insertion member 2102 is configured to facilitatedelivery of the occlusion device from a microcatheter (not shown in FIG.21) into the sac of the aneurysm. The occlusion device 2110 is shown inan expanded configuration and can be moved between a compressed orcollapsed configuration and the expanded configuration in the same orsimilar manner as described above for previous embodiments.

The occlusion device 2110 includes a series of expandable portions 2120,2122, 2124, 2126, 2128 separated by a series of constricted portions2130, 2132, 2134, 2136. The expandable portions 2120, 2122, 2124, 2126,2128 can be configured to expand to any suitable multi-dimensionalshape, including, for example, that resembling a sphere, a disc, aparabola, or the like. Additionally, each expandable portion 2120, 2122,2124, 2126, 2128 can have an expanded shape distinct from an expandedshape of another expandable portion.

When the occlusion device 2110 is in its expanded configuration, asshown in FIG. 21, the expandable portions 2120, 2122, 2124, 2126, 2128are more porous and less dense then the constricted portions 2130, 2132,2134, 2136. The density and/or porosity of each expandable portion 2120,2122, 2124, 2126, 2128 can be varied from the other expandable portions2120, 2122, 2124, 2126, 2128, and the density and/or porosity of eachexpandable portion 2120, 2122, 2124, 2126, 2128 can be varied along alength and/or width of the respective expandable portion. For example, afirst expandable portion 2120 can be more dense and/or less porousproximate to a first constriction portion 2130 and less dense and/ormore porous at a middle, wider portion of the first expandable portion2120. Additionally, the expandable portions 2120, 2122, 2124, 2126, 2128are each configured to have a width greater than when the occlusiondevice 2110 is in its collapsed configuration, and the constrictedportions 2130, 2132, 2134, 2136 are each configured to have a widthnarrower than a width of the expandable portions 2120, 2122, 2124, 2126,2128. As such, the occlusion device 2110 is configured to bend, curve,and/or fold at the constricted portions 2130, 2132, 2134, 2136 to helpcomply with the shape of the aneurysm.

When the occlusion device 2110 is in its expanded configuration, thefirst expandable portion 2120 is configured to have a width greater thanthe width of the other expandable portions 2122, 2124, 2126, 2128. Thefirst expandable portion 2120 can be, as illustrated in FIG. 21, themost proximal of the expandable portions 2120, 2122, 2124, 2126, 2128.The first expandable portion 2120 is configured to be positioned over aneck of the aneurysm when the occlusion device 2110 is disposed withinthe aneurysm in its expanded configuration. In this manner, the firstexpandable portion 2120 is configured to act as a flow disruptor at theneck of the aneurysm to help limit the flow of blood into the aneurysmfrom the parent blood vessel. The remaining, more distal, expandableportions 2122, 2124, 2126, 2128 are configured to be packed into theaneurysm to embolize the aneurysm.

The occlusion device 2110 includes a first radiopaque marker 2142coupled to a first end 2112 of the implant and a second radiopaquemarker 2144 coupled to a second end 2114 of the implant. The radiopaquemarkers 2142, 2144 are configured to be wholly disposed within the sacof the aneurysm when the occlusion device 2110 is disposed in theaneurysm in its expanded configuration.

FIG. 22 illustrates another embodiment of a medical device. The medicaldevice 2200 can include the same or similar features and functions asdescribed above for previous embodiments. For example, the medicaldevice 2200 includes an occlusion device 2210 and an insertion portionor member 2202. The occlusion device 2210 is sized to occupy the sac ofthe aneurysm, and the insertion member 2202 is configured to facilitatedelivery of the occlusion device into the sac of the aneurysm. Theocclusion device 2210 is shown in an expanded configuration and can bemoved between a compressed or collapsed configuration and the expandedconfiguration in the same or similar manner as described above forprevious embodiments.

The occlusion device 2210 includes a first porous member 2220 and asecond porous member 2230. The first porous member 2220 includes aporous mesh configured to have a multi-dimensional shape when theocclusion device 2210 is in its expanded configuration. As such, thefirst porous member 2220 has a second width in the expandedconfiguration that is greater than a first width of the first porousmember in the collapsed configuration. The first porous member 2220 canbe configured to expand to any suitable multi-dimensional shape,including, for example, that resembling a parabola, as shown in FIG. 22,a sphere, a disc, or the like. The first porous member 2220 isconfigured to be positioned over a neck of the aneurysm when theexpandable member 2210 is disposed within the sac of the aneurysm todisrupt and/or stop the flow of blood into the aneurysm from the parentblood vessel. Additionally, the porous mesh of the first porous member2220 is configured to promote endothelial cell attachment at the neck ofthe aneurysm, which can help to heal over the neck of the aneurysm.

The second porous member 2230 includes a porous mesh configured to havea multi-dimensional shape when the occlusion device 2210 is in itsexpanded configuration. As such, the second porous member 2230 has afourth width in the expanded configuration greater than a third width ofthe second porous member in the collapsed configuration. The secondporous member 2230 can be configured to expand to any suitablemulti-dimensional shape, including, for example, that resembling a tube,as shown in FIG. 22, a sphere, a disc, a parabola, or the like. In theembodiment illustrated in FIG. 22, the second width of the first porousmember 2220 is greater than the fourth width of the second porous member2230. The second porous member 2230 is configured to be disposed withinthe sac of the aneurysm such that the first porous member 2220 isdisposed between the second porous member 2230 and the neck of theaneurysm. The second porous member 2230 is configured to be packed intothe aneurysm to embolize the aneurysm.

A radiopaque marker 2244 is disposed between the first porous member2220 and the second porous member 2230, and can be used to couple thefirst and second porous members. The occlusion device 2210 is configuredto bend, curve, and/or fold at the radiopaque marker 2244, which canhelp the occlusion device 2210 comply with the shape of the sac of theaneurysm. Another radiopaque marker 2242 can be disposed on a proximateend of the occlusion device 2210, and can be used to couple theinsertion portion 2202 to the occlusion device. The radiopaque markers2242, 2244 arc configured to be wholly disposed within the sac of theaneurysm when the occlusion device 2210 is disposed in the aneurysm inits expanded configuration.

FIGS. 23A and 23B illustrate another embodiment of a medical device. Themedical device 2300 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 2300 includes a first porous member 2320, a second porousmember 2330, and an insertion portion or member 2302 removably couplableto the first and second porous members 2320, 2330.

The first porous member 2320 has a first end 2322 and a second end 2324.As shown in FIG. 23A, the first porous member 2320 has a collapsedconfiguration for insertion through a blood vessel. In its collapsedconfiguration, the first porous member 2320 is substantially elongatewith a first length. As shown in FIG. 14B, the first porous member 2320has an expanded configuration for occupying a sac of an aneurysm. Whenthe first porous member 2320 is in its expanded configuration, it has athree-dimensional shape and defines an open interior region 2326. Thefirst porous member 2320 can have any suitable three-dimensional shape.For example, the first porous member 2320 can be configured to curveinto a substantially spherical shape, as shown in FIG. 23B.Additionally, in its expanded configuration, the first porous member2320 includes a first segment configured to overlap with a secondsegment, which can be similar in many respects as described above withrespect to occlusion devices 1410 and 1510, for example. For example,the first porous member 2320 can include a mesh having a first segmentconfigured to overlap with a second segment of the porous mesh to form ahigher density portion of the first porous member 2320.

The second porous member 2330 has a first end 2332 and a second end2334. The second porous member 2330 has a collapsed, first,configuration (not shown in FIG. 23A or 23B) for insertion through ablood vessel. In its collapsed configuration, the second porous member2330 is substantially elongate with a second length less than the firstlength of the first porous member, and is configured to occupy a firstvolume. As shown in FIGS. 23A and 23B, the second porous member 2330 hasan expanded, second, configuration for occupying at least a portion ofthe volume of the sac of the aneurysm. When the second porous member2330 is in its expanded configuration, it has a three-dimensional shapeand is configured to occupy a second volume greater than the firstvolume. The second porous member 2330 can have any suitablethree-dimensional shape. For example, the second porous member 2330 canbe configured to expand into a substantially ball (e.g., spherical,round, oblong, or the like) shape, as shown in FIGS. 23A and 23B. In theexpanded configuration, the second porous member 2330 can have aporosity the same as, or different than, a porosity of the first porousmember 2320. The second porous member 2330 is configured to be disposedin the interior region 2326 of the first porous member 2320 when each ofthe first porous member and the second porous member are in the deployedor expanded configurations.

In the embodiment illustrated in FIGS. 23A and 23B, the second porousmember 2330 is coupled to the first porous member 2320. Specifically,the first end 2322 of the first porous member 2320 is coupled to thefirst end 2332 of the second porous member 2330. At least one of thefirst porous member 2320 and the second porous member 2330 includes aradiopaque marker. As shown in FIG. 23A, a first radiopaque marker 2342can be disposed on the first ends 2322, 2332 of the first and secondporous members 2320, 2330 to couple the first and second porous memberstogether. A second radiopaque marker 2344 can be disposed on the secondend 2334 of the second porous member 2330. When the first and secondporous members 2320, 2330 arc in their respective expandedconfigurations, the second radiopaque marker 2344 is disposed within theinterior region defined by the first porous member 2320.

In use, the first and second porous members 2320, 2330, and the firstand second radiopaque markers 2342, 23214, are wholly disposed withinthe aneurysm. The second porous member 2330 can be inserted into theaneurysm first and assume its expanded configuration therein. The firstporous member 2320 can then be inserted into the aneurysm such that thefirst porous member curves, coils, or otherwise wraps around the secondporous member 2330 as the first porous member moves to its expandedconfiguration. The first porous member 2320 is configured to be disposedwithin the aneurysm such that a portion of the first porous member isdisposed over the neck of the aneurysm. For example, the higher densityportion of the first porous member 2320 at which the first segmentoverlaps the second segment can be positioned over the neck of theaneurysm to promote endothelial cell attachment at the aneurysm neck.The second porous member 2330 can help to embolize the aneurysm byproviding additional porous mesh within the sac of the aneurysm for cellattachment and/or clot formation. As such, the second porous memberoccupies a portion of the volume of the sac of the aneurysm such thatblood flow through the aneurysm is further inhibited.

Although the medical device 2300 includes discrete first and secondporous members 2320, 2330, respectively, in other embodiments, the firstand second porous members can be differently constructed. For example,referring to FIG. 24, an embodiment of a medical device 1200 isillustrated. The medical device 2400 can include the same or similarfeatures and functions as described above for medical device 2400, orother previous embodiments. For example, the medical device 2400includes a first porous member 2420, a second porous member 2430, and aninsertion portion or member (not shown in FIG. 24) removably couplableto the first and second porous members. Each of the first porous member2420 and the second porous member 2430 can be similar in form andfunction as the first porous member 2320 and the second porous member2330, respectively, described above.

In the embodiment illustrated in FIG. 24, however, the second porousmember 2430 is monolithically constructed with the first porous member2420. It should be noted that in FIG. 24, the first and second porousmembers 2420, 2430, are shown in an expanded configuration but thesecond porous member 2430 is shown spaced apart from the first porousmember 2420 for illustration purposes only. In use, in their respectivedeployed or expanded configurations, the second porous member 2430 isdisposed within an interior region 2426 defined by the first porousmember 2420 in a similar manner as that illustrated in FIG. 23 withrespect to medical device 2300. Additionally, the medical device 2400includes two radiopaque markers 2442, 2444. A first radiopaque marker2442 is disposed at an end of a porous mesh of the first porous member2420, and the second radiopaque marker 2444 is disposed at an opposingend of porous mesh of the second porous member 2430.

In some embodiments, a medical device includes an occlusion device thathas a substantially continuous outer surface when in an expandedconfiguration. Referring to FIGS. 25A and 25B, a portion of a medicaldevice 2500 according to an embodiment is illustrated in a collapsedconfiguration and an expanded configuration, respectively. The medicaldevice 2500 can include the same or similar features and functions asdescribed herein for other embodiments. For example, the medical device2500 can include an occlusion device 2510 configured to move from thecollapsed configuration (e.g., for delivery through a blood vessel) tothe expanded configuration (e.g., for deployment within an aneurysm).The occlusion device 2510 includes at least a first portion 2520 and asecond portion 2530, and can include additional portions 2540, 2550,2560. When the occlusion device 2510 is in its expanded configuration,the occlusion device 2510 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the portions 2520, 2530,2540, 2550, 2560 overlap. For example, edges of the first portion 2520and the second portion 2530 can overlap, as shown in FIG. 25B. In otherwords, the occlusion device 2510 moves into the expanded configurationsuch that few or no openings or spaces remain between edges of theportions 2520, 2530, 2540, 2550, 2560 of the occlusion device 2510.

FIG. 26A illustrates a portion of another embodiment of a medicaldevice. The medical device 2600 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 2600 includes an occlusion device 2610 and aninsertion portion or member (not shown in FIG. 26A). The occlusiondevice 2610 is shown in an expanded configuration and can be movedbetween a compressed or collapsed configuration in which the occlusiondevice 2610 is substantially elongate and the expanded configuration inthe same or similar manner as described above for previous embodiments.

The occlusion device 2610 includes a ribbon-like strand of porous meshand includes petal-like portions or sections 2625 and 2627 along itslength. At least a portion of the porous mesh is configured to bepositioned over a neck of an aneurysm when the occlusion device 2610 isin the expanded configuration. The occlusion device 2610 includes afirst portion 2620 that includes the petal-like portions 2627 and asecond portion 2630 that includes the petal-like portions 2627. Thepetal-like portions 2625 of the second portion 2630 are larger than thepetal-like portions 2627 of the first portion 2620 such that when theocclusion device 2610 is moved to its expanded configuration, thepetal-like portions 2625 of the second portion at least partiallyoverlap the petal-like portions 2627 of the first portion 2620. Duringdeployment of the occlusion device 2610 (e.g., when moved from itscollapsed configuration to its expanded configuration) the petal-likeportions 2625 of the second portion 2630 will deploy first, and then thepetal-like portions 2627 of the first portion 2620 will deploy at leastpartially within an interior region defined by the second portion 2630.The petal-like portions 2625 of the second portion 2630 can be sized andconfigured to be disposed at a neck of an aneurysm when the occlusiondevice 2610 is in the expanded configuration. The petal-like portions2627 of the first portion 2620 can be formed in a smaller diameterfixture than the petal-like portions 2625, and can be sized andconfigured to substantially fill the aneurysm and to hold the secondportion 2630 in place at the neck of the aneurysm when the occlusiondevice 2610 is in the expanded configuration. For example, thepetal-like portions 2627 of the first portion 2620 can have a diameterof about 2 mm-12 mm, and the petal-like portions 2625 of the secondportion 2630 can have a corresponding diameter of about 1 mm larger thanthe petal-like portions 2627 of the first portion 2620. For example, thepetal-like portions 2625 of the second portion 2630 can be about 3 mm-13mm. FIG. 26B is a schematic illustration of the occlusion device 2610 inits expanded configuration showing the positional relationship of thefirst portion 2620 to the second portion 2630.

As described for previous embodiments, a first radiopaque marker 2642 iscoupled to a first end of the occlusion device 2610 and a secondradiopaque marker (not shown) is coupled to a second end of theocclusion device 2610. The occlusion device 2610 is configured to bewholly disposed within the aneurysm such that the radiopaque markers arewholly disposed within the aneurysm sac and the porous mesh is disposedover the neck of the aneurysm. In some embodiments, the radiopaquemarkers are configured to be positioned at a side of the aneurysm (i.e.,disposed away from the neck of the aneurysm).

FIG. 27 illustrates a portion of another embodiment of a medical device.The medical device 2700 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 2700 includes an occlusion device 2710 and an insertionportion or member (not shown in FIG. 27). The occlusion device 2710 isshown in an expanded configuration and can be moved between a compressedor collapsed configuration in which the occlusion device 2710 issubstantially elongate and the expanded configuration in the same orsimilar manner as described above for previous embodiments.

As with the previous embodiment, the occlusion device 2710 includes aribbon-like strand of porous mesh. At least a portion of the porous meshis configured to be positioned over a neck of an aneurysm and at leastanother portion of the porous mesh substantially fills the volume of theaneurysm when the occlusion device 2710 is in the expandedconfiguration. The occlusion device 2710 includes a first portion 2720and a second portion 2730. In this embodiment, each of the first portion2720 and the second portion 2730 form a sphere when the occlusion device2710 is in its expanded configuration. One of the first portion 2720 orthe second portion 2730 can be configured to be disposed at a neck ofthe aneurysm and the other of the first portion 2720 or the secondportion 2730 can substantially fill the volume of the aneurysm. Forexample, in this embodiment, the first portion 2720 can be configured tobe deployed at the dome of an aneurysm and serve as an anchor for thesecond portion 2730 and the second portion 2730 can be disposed acrossthe neck of the aneurysm when the occlusion device 2710 is in theexpanded configuration. The occlusion device 2710 can also includeradiopaque markers (not shown) as described above for previousembodiments.

FIGS. 28A and 28B illustrate another embodiment of a medical device. Themedical device 2800 can include the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 2800 includes an occlusion device 2810 and an insertionportion or member (not shown). The occlusion device 2810 is shown in anexpanded configuration and can be moved between a compressed orcollapsed configuration as shown in FIG. 28B and the expandedconfiguration as shown in FIG. 28A in the same or similar manner asdescribed above for previous embodiments.

As with the previous embodiment, the occlusion device 2810 includes aribbon-like strand of porous mesh that includes a first portion 2820 inthe form of a disc-shaped structure and a second portion 2830 thatincludes petal-like portions or sections along its length (similar tothe embodiment of FIG. 26A). The disc or spherical shaped structure ofthe first portion 2820 can be disposed at various locations along thelength (e.g., middle, end, etc.) of the occlusion device 2810. At leasta portion of the porous mesh is configured to be positioned over a neckof an aneurysm when the occlusion device 2810 is in the expandedconfiguration. In this embodiment, when the occlusion device 2810 is inthe expanded configuration, the petal-like portions of the secondportion 2830 at least partially overlap the disc-shaped structure of thefirst portion 2820. For example, when the occlusion device 2810 is inits expanded configuration, the petal-like portions of the secondportion 2830 can define a diameter greater than a diameter defined bythe disc or spherical shaped structure of the first portion 2820. Theocclusion device 2810 can also include a first radiopaque marker 2842coupled to a first end 2812 of the occlusion device 2810 and a secondradiopaque marker (not shown) coupled to a second end (not shown) of theocclusion device 2810. The occlusion device 2810 can also include aconnector 2852 coupled to a first end 2812 of the occlusion device 2810.

When the occlusion device 2810 is in its expanded configuration, theocclusion device 2810 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the petal-like portions 2825overlap each other (in a similar manner as the embodiment of FIGS. 25Aand 25B), and at least partially overlap the disc-shaped portion 2820.The occlusion device 2810 can move into the expanded configuration suchthat few or no openings or spaces remain between petal-like portions2825 of the occlusion device 2810.

FIGS. 29A and 29B illustrate a portion of another embodiment of amedical device. The medical device 2900 can include the same or similarfeatures and functions as described above for previous embodiments. Forexample, the medical device 2900 includes an occlusion device 2910 andan insertion portion or member (not shown in FIGS. 29A and 29B). Theocclusion device 2910 can be moved between a collapsed configuration asshown in FIG. 23 and an expanded configuration as shown in FIG. 24.

Similar to the embodiment of FIG. 26A, the occlusion device 2910includes a ribbon-like strand of porous mesh that includes petal-likeportions or sections 2925 along its length. At least a portion of theporous mesh is configured to be positioned over a neck of an aneurysmwhen the occlusion device 2910 is in the expanded configuration. Whenthe occlusion device 2910 is in its expanded configuration, theocclusion device 2910 has a three-dimensional shape (e.g., asubstantially spherical shape) with a substantially continuous outersurface such that edges of at least two of the petal-like portions 2925overlap each other as shown in FIG. 29B.

In this embodiment, when the implantable implant 2910 is formed, theribbon-like strand of porous mesh is wrapped around the forming fixturein a multi-directional fashion. For example, a portion of the mesh canbe wrapped in a continuous manner around the fixture as indicated at Cin FIG. 29A, and a portion of the mesh can be wrapped in an s-shapemanner as indicated at S in FIG. 29A. With such forming, when theocclusion device 2910 is moved to its expanded configuration, thepetal-like portions 2925 that have been formed by wrapping in acontinuous manner will follow each other (each petal-like portion 2925will cause the adjacent petal-like portion 2925 to collapse), and thepetal-like portions 2925 that have been formed in a s-shape manner willindividually self-deploy or collapse. The multi-directional heat formingof the occlusion device 2910 can allow the occlusion device 2910 todeploy fragmented within an aneurysm.

In this embodiment, the medical device 2900 also includes a PT coil orPT strand 2935 disposed along the length of the occlusion device 2910 toprovide for a portion of the occlusion device 2910 to be radiopaque. Asshown in FIG. 29A, the PT strand 2935 is disposed along a length of theocclusion device 2910 and across or within the petal-like portions 2925.The PT strand 2935 can be coupled to, for example, marker bands (notshown) disposed on a proximal end and a distal end of the occlusiondevice 2910. In some embodiments, a PT strand 2935 can be braided withinthe mesh of the occlusion device 2910.

In some embodiments, the PT strand 2935 can also be used to preventover-stretching of the occlusion device 2910 when being delivered to atreatment site. For example, as described above, the PT strand 2935 canbe coupled to the proximal end and the distal end of the occlusiondevice 2910. Thus, the PT strand 2935 can define a maximum length inwhich the occlusion device 2910 can be stretched or extended lengthwiseduring insertion and prevent overstretching. In alternative embodiments,a separate component can be used to limit the length of the occlusiondevice 2910. For example, in some embodiments, a separate wire member inaddition to a PT strand can be used. In some embodiments, an occlusiondevice may not include a PT strand, such as PT strand 2935. In suchembodiments, a separate wire member can be coupled to the proximal endand distal end of the expandable member and used to limit the length oramount of stretch of the occlusion device in a similar manner.

In some embodiments, a medical device can include a strand formed with,for example, a suture that extends along or within the medical device.The suture strand can reinforce the medical device along its length. Insome embodiments, a radiopaque coil can be placed over the suture strandto enhance visibility of the medical device under fluoroscopy.

FIGS. 30A-30C illustrate a portion of another embodiment of a medicaldevice. The medical device 3000 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 3000 includes an occlusion device 3010 and aninsertion portion or member (not shown in FIGS. 30A-30C). The occlusiondevice 3010 can be moved between a collapsed configuration (as shown inFIG. 30A, a partially expanded configuration as shown in FIG. 30B, andan expanded configuration as shown in FIG. 30C.

The occlusion device 3010 includes a ribbon-like strand of porous meshthat includes a first portion 3020 (see FIGS. 30A-30C) and a secondportion 3030 (shown only in FIG. 30C). In this embodiment, the firstportion 3020 and the second portion 3030 are separate components thatcan be deployed together. The first portion 3020 includes disc-shapedportions 3045 along its length, and the second portion 3030 includespetal-like portions 3025, as described above for previous embodiments.When the occlusion device 3010 is in its expanded configuration, theocclusion device 3010 has a three-dimensional shape (e.g., asubstantially spherical shape) as shown in FIG. 30A.

During deployment of the medical device 3000, the second portion 3030can be deployed first such that the petal-like portions 3025 are movedto an expanded configuration and define an interior region 3036. Thefirst portion 3020 can then be deployed such that the disc-shapeportions 3045 will collapse upon each other (as shown in FIGS. 30B and30C) within the interior region 3036 of the second portion 3030, asshown in FIG. 30C. In other words, when the occlusion device 3010 is inthe expanded configuration, the second portion 3030 at least partiallyoverlaps the first portion 3020, as shown in FIG. 30C. At least aportion of the porous mesh is configured to be positioned over a neck ofan aneurysm when the occlusion device 3010 is in the expandedconfiguration. For example, when the occlusion device 3010 is in itsexpanded configuration, the second portion 3030 can be disposed at theneck of the aneurysm to disrupt blood flow, and the first portion 3020can help occlude the aneurysm at a relatively fast rate. Although thisembodiment illustrates the first portion 3020 and the second portion3030 as separate components, in an alternative embodiment, the firstportion 3020 and the second portion 3030 can be formed with a singlemesh component.

In this embodiment, the medical device 3000 can also include a PT coilor PT strand (not shown) disposed along the length of first portion 3020and/or the second portion 3030 of the occlusion device 3010 in a similarmanner as described above for medical device 2900. The PT strand can becoupled to a first marker band 3042 disposed at a first end 3012 of theocclusion device 3010 and a second marker band 3044 disposed on a secondend of the occlusion device 3010 as shown in FIG. 30C. As describedabove, the PT strand can be braided within the mesh of the occlusiondevice 3010. As shown in FIGS. 30B and 30C, the expandable member 3010also includes a connector member 3052 that can be used to couple theexpandable member 3010 to a delivery device.

FIGS. 31A and 31B illustrate another embodiment of a medical device. Amedical device 3100 can include all the same or similar features andfunctions as described above for previous embodiments. For example, themedical device 3100 includes an occlusion device 3110, an insertionportion or member 3102, a first radiopaque marker 3142 coupled to afirst end 3112 of the occlusion device 3110 and a second radiopaquemarker 3144 coupled to a second end 3114 of the occlusion device 3110.The occlusion device 3110 can be moved between a collapsed configuration(not shown) and an expanded configuration as shown in FIGS. 31A and 31B.

In this embodiment, the occlusion device 3110 includes three tubular orrounded strands 3120, 3130 and 3115 formed of a porous mesh similar tothe tubular structures described above, for example, with respect toFIGS. 19 and 20. In some embodiments, the strands 3120, 3130 and 3115can be braided. In alternative embodiments, the strands 3120, 3130 and3115 can be formed with ribbon-like strands of porous mesh rather thantubular strands. When the occlusion device 3110 is in its expandedconfiguration, at least a portion of the tubular strands 3120, 3130 and3115 can overlap each other as shown in FIG. 31B. The occlusion device3110 can be used to fill a volume of an aneurysm and can be used aloneor in conjunction with another occlusion device to fill the volume of ananeurysm.

The tubular mesh can be, for example, 1 mm tubular mesh. In thisembodiment, the tubular strands 3120, 3130, 3115 can be heat-shaped suchthat the occlusion device 3110 has a 2D configuration when the occlusiondevice 3110 is in its expanded configuration. In this embodiment, threetubular strands are included, but in alternative embodiments a differentnumber of tubular strands can be included. For example, an occlusiondevice can be formed with 1-10 tubular strands. The tubular strands3120, 3130 and 3115 can be coupled together at various locations alongtheir lengths with marker bands, such as marker band 3146 shown in FIG.31B. In alternative embodiments, the tubular strands can be twistedtogether, or braided together rather than using marker bands. In someembodiments, the strands are not coupled together.

FIG. 32 illustrates another embodiment of a medical device includingtubular structures. A medical device 3200 can include all the same orsimilar features and functions as described above for previousembodiments. For example, the medical device 3200 includes an occlusiondevice 3210 and an insertion portion or member 3202. Although not shownin FIG. 32, the medical device 3200 can also include radiopaque markerscoupled to end portions to the occlusion device 3210. The occlusiondevice 3210 can be moved between a collapsed configuration (not shown)and an expanded configuration as shown in FIG. 32.

The occlusion device 3210 includes three tubular or rounded strands3220, 3230 and 3215 formed of a porous mesh similar to the tubularstrands described above for medical device 2000. When the occlusiondevice 3210 is in its expanded configuration, at least a portion of thetubular strands 3220, 3230 and 3215 can overlap each other as shown inFIG. 32. In this embodiment, the tubular strands 3220, 3230, 3215 can beheat-shaped to have a 3D configuration when the occlusion device 3210 isin the expanded configuration. In this embodiment, three tubular strandsare included, but in alternative embodiments a different number oftubular strands can be included. For example, an occlusion device can beformed with 1-10 tubular strands. The tubular strands 3220, 3230 and3215 can be coupled together at various locations along their lengthswith marker bands (not shown) as described above for medical device3100, or can be coupled using other coupling methods, such as beingtwisted together, or braided together. In some embodiments, the tubularstrands are not coupled together.

FIG. 33 illustrates another embodiment of a medical device includingtubular structures. A medical device 3300 can include all the same orsimilar features and functions as described above for previousembodiments. For example, the medical device 3300 includes an occlusiondevice 3310 and an insertion portion or member 3302. Although not shownin FIG. 33, the medical device 3300 can also include radiopaque markerscoupled to end portions to the occlusion device 3310, such as radiopaquemarker 3342 coupled to an end 3312 shown in FIG. 33. The occlusiondevice 3310 can be moved between a collapsed configuration (not shown)and an expanded configuration as shown in FIG. 33.

In this embodiment, the occlusion device 3310 includes a single tubularor rounded braid structure 3315 formed of a porous mesh similar to thetubular structures described above for medical devices 2000 and 2100.When the occlusion device 3310 is in its expanded configuration, atleast a first portion of the tubular structure 3315 can overlap a secondportion of the tubular structure 3315, as shown in FIG. 33. In thisembodiment, the tubular structure 3315 is formed in a 2D shapeconfiguration and the tubular structure is formed with a larger porositymesh than medical devices 2000 and 2100. For example, the tubularstructure 3315 can be formed with a 3 mm mesh.

FIGS. 34A and 34B illustrate a portion of another embodiment of amedical device. The medical device 3400 can include the same or similarfeatures and functions as described above for previous embodiments. Themedical device 3400 includes an occlusion device 3410 and can include aninsertion portion or member (not shown in FIGS. 34A and 34B). Theocclusion device 3410 can be moved between a collapsed configuration asshown in FIG. 34A and an expanded configuration as shown in FIG. 34B.

In this embodiment, the occlusion device 3410 includes a first portion3420 formed with a ribbon-like strand of porous mesh and includespetal-like portions 3425, and a second portion 3430 in the form of atubular or rounded strand 3415 formed of a porous mesh similar to thetubular strands described above, for example, with respect to FIGS. 31A,31B and 32. The tubular strand 3415 can be heat formed as either a 2D or3D configuration. In some embodiments, the tubular strand 3415 can bebraided.

When the occlusion device 3410 is in its expanded configuration, atleast a portion of the first portion 3420 (e.g., petal-like portions3425) can overlap the tubular strand 3415 of the second portion 3430. Atleast a portion of the occlusion device 3410 is configured to bepositioned over a neck of an aneurysm when the occlusion device 3410 isin the expanded configuration. The petal-like portions 3425 and thetubular strand 3415 can each be a variety of different sizes (e.g.,diameters), such that when the occlusion device 3410 is moved to itsexpanded configuration, the petal-like portions 3425 of the secondportion 3410 define an interior region and the tubular strand 3415 ofthe first portion 3420 substantially fills the interior region of thesecond portion 3430. Thus, the tubular strand 3415 can be used as afiller to substantially fill a volume of an aneurysm as described abovefor occlusion devices 3110 and 3210.

The first portion 3420 and the second portion 3430 can be coupledtogether, for example, with marker bands at end portions of the firstportion 3420 and the second portion 3430 and/or at other locations alonga length of each of the first portion 3420 and the second portion 3430.The first portion 3420 and the second portion 3430 can have the same orsubstantially the same length or can have different lengths. Forexample, in some embodiments, the second portion 3430 can be longer thanthe first portion and vice versa.

The occlusion device 3410 also includes a first radiopaque marker band3442 disposed at a first end 3412 of the expandable member and a secondradiopaque marker band 3444 disposed at a second end 3414 of theocclusion device 3410 as shown in FIG. 34C, which is a schematicillustration of the occlusion device 3410. As shown in FIG. 34C, whichis a schematic illustration of the occlusion device 3410, the expandablemember 3410 also includes a connector member 3452 that can be used tocouple the expandable member to a delivery device.

FIGS. 35A and 35B illustrate a portion of another embodiment of amedical device. The medical device 3500 can include the same or similarfeatures and functions as described above for previous embodiments. Forexample, the medical device 3500 includes an occlusion device 3510 andan insertion portion or member 3502. The occlusion device 3510 can bemoved between a collapsed configuration, as shown in FIG. 35B and anexpanded configuration, as shown in FIG. 35A.

The occlusion device 3510 includes a ribbon-like strand of porous meshthat includes a first portion 3520 and a second portion 3530 formed as asingle component. In this embodiment, when the occlusion device 3510 isin the expanded configuration, the second portion 3530 forms a ball-likestructure that defines an interior region 3536 and the first portion3520 can be deployed within the interior region 3536. Specifically,during deployment of the medical device 3500, the second portion 3530can be deployed first such that it can be expanded to the ball-shapedstructure within an aneurysm, and then the first portion 3520 can bedeployed within the interior region 3536 to substantially fill thesecond portion 3530 as shown in FIG. 35A.

FIGS. 36A-36C illustrate a portion of another embodiment of a medicaldevice. The medical device 3600 can include the same or similar featuresand functions as described above for previous embodiments. For example,the medical device 3600 includes an occlusion device 3610 and aninsertion portion or member 3602. The occlusion device 3610 can be movedbetween a collapsed configuration, as shown in FIG. 36B and an expandedconfiguration, as shown in FIG. 44.

The occlusion device 3610 is an example of a multi-layer implant thatincludes a ribbon-like strand of porous mesh that includes a firstportion 3630, a second portion 3620 and a third portion 3615 formed witha single mesh component. Such an embodiment may be desirable in that theimplant can fit in a small delivery catheter, but can have high flowdisruption by having more than two layers of material, and forming thelayers in-vivo. For example, in this embodiment, when the occlusiondevice 3610 is in the expanded configuration, the second portion 3620can be expanded within the third portion 3615 and the first portion 3630can be expanded within the second portion 3620. Specifically, duringdeployment within an aneurysm A, as shown in FIG. 36C, the medicaldevice 3600 can first be inserted into a delivery catheter 3604 suchthat the occlusion device 3610 is moved to its collapsed configuration.At the deployment site, the occlusion device 3610 can be moved outsidethe delivery catheter 3604 and deployed within an aneurysm. Duringdeployment, the third portion 3615 can be deployed first, then thesecond portion 3620 can be deployed within an interior region defined bythe third portion 3615, and then the first portion 3630 can be deployedwithin an interior region defined by the second portion 3620. FIG. 36Cillustrates the occlusion device 3610 with the third portion 3615 andthe second portion 3620 deployed and the first portion 3630 still withinthe catheter 3604. In some embodiments, the insertion portion 3602 canbe coupled to the second portion 3620, such that during detachment ofthe insertion portion 3602 (e.g., after the occlusion device 3610 hasbeen deployed within an aneurysm), the detachment can occur inside thesecond portion to avoid any part of the implant from extending orhanging within the blood vessel V.

FIGS. 37A, 37B and 38 illustrate a portion of a medical device 3700according to an embodiment. The medical device 3700 can include the sameor similar features and functions as described herein for otherembodiments. For example, the medical device 3700 can include anocclusion device 3710 configured to move from the collapsedconfiguration (e.g., for delivery through a blood vessel) to theexpanded configuration (e.g., for deployment within an aneurysm) and aninsertion member or device 3754 (shown in FIG. 37B) as described herein.

Similar to the occlusion device 2910, the occlusion device 3710 includesa ribbon-like strand of porous mesh that includes one or more petal-likeportions or sections 3725 along its length. In this embodiment, thereare four petal-like portions 3725 included within an outer petal segment3791 of the occlusion device 3710 and three petal-like portions 3725included within an inner petal segment 3790 of the occlusion device3710.

At least a portion of the porous mesh can be configured to be positionedover a neck of an aneurysm when the occlusion device 3710 is in theexpanded configuration. When the occlusion device 3710 is in itsexpanded configuration, the occlusion device 3710 has athree-dimensional shape (e.g., a substantially spherical shape) with asubstantially continuous outer surface such that a portion (e.g., edges)of at least two of the petal-like portions 3725 overlap each other asshown in FIG. 37B. For example, as the occlusion device 3710 is beingdeployed within an aneurysm, the petal-like portions 3725 of the outerpetal segment 3791 expands first and forms an outer layer that coversthe aneurysm. The petal-like portions 3725 of the inner petal segment3790 then form a second spherical layer of material inside thepetal-like portions 3725 of the outer petal portion 3791 to providegreater surface area to further promote thrombosis.

In this embodiment, a suture strand 3735 extends along the length of theocclusion device 3710 to provide reinforcement to the occlusion device3710 and can also provide for a radiopaque coil to be disposed over atleast a portion of the suture strand 3735 to provide visibility of theocclusion device 3710 during, for example, fluoroscopy. As shown inFIGS. 37A and 37B, the suture strand 3735 is disposed along a length ofthe occlusion device 3710 and across or within the petal-like portions3725. The suture strand 3735 can be coupled to, for example, markerbands 3742 and 3744 disposed on a proximal end and a distal end,respectively, of the occlusion device 3710.

In this embodiment, the outer petal segment 3791 and the inner petalsegment 3790 can be formed as separate components and coupled togetherby the suture strand 3735. This creates an articulation point or joint3779 between the outer petal segment 3791 and the inner petal segment3790. For example, the inner petal segment 3790 can include the markerband 3742 at a proximal end and a marker band 3794 at a distal end. Theouter petal segment 3791 can include the marker band 3744 at a distalend and a marker band 3795 at a proximal end. The articulation joint3779 is defined where the marker band 3794 and the marker band 3795 arecoupled to the suture strand 3735.

The articulation joint 3779 can provides greater freedom of motion ofthe petal-like portions 3725, which can allow more uniform expansion ofthe petal-like portions 3725. In 3790, the separate construction of theouter petal segment 3791 and the inner petal segment 3790 can allow forone spherical layer of the occlusion device to be formed at a time,which may be advantageous and/or easier to manufacture. The ability tomanufacture the occlusion device 3710 in multiple segments can alsoallow for the addition to, or removal of, segments of an occlusiondevice to provide a selected length or size of the occlusion device tomeet a particular need.

As shown in FIG. 37A, the occlusion device 3710 can also include alead-in member 3776 coupled to a distal end portion of the occlusiondevice 3710 with the marker band 3744. The lead-in member 3776 can beformed with, for example a shape memory material such, as nitinol, suchthat the lead-in member 3776 has a biased curved shape when notconstrained within, for example a cannula (not shown). In someembodiments, the lead-in member 3776 can be coupled to the distal endportion of the occlusion device 3710 with a crimp. Although not shown,the occlusion device 3710 can also include a coupling member toreleasably couple the occlusion device 3710 to the delivery device 3754as described above for previous embodiments.

FIG. 38 illustrates another embodiment of a medical device 3800 thatincludes an occlusion device 3810 that has multiple articulation joints3879. The medical device 3800 can include the same or similar featuresand functions as described herein for other embodiments. For example,the medical device 3800 can be configured to move from a collapsedconfiguration a shown in FIG. 38 (e.g., for delivery through a bloodvessel) to an expanded configuration (not shown) (e.g., for deploymentwithin an aneurysm). The medical device 3800 can also include aninsertion member or device (not shown in FIG. 38) to which the occlusiondevice 3810 can be releasably coupled, as described above for previousembodiments.

The occlusion device 3810 includes a ribbon-like strand of porous meshthat includes one or more petal-like portions or sections 3825 along itslength. In this embodiment, there are three petal-like portions 3825included within a first petal segment 3892 of the occlusion device 3810,four petal-like portions 3825 included within a second petal segment3891, and three petal-like portions 3825 included within a third petalsegment 3890 of the occlusion device 3810.

As with the previous embodiment, at least a portion of the porous meshcan be configured to be positioned over a neck of an aneurysm when theocclusion device 3810 is in the expanded configuration. When theocclusion device 3810 is in its expanded configuration, the occlusiondevice 3810 can have a three-dimensional shape (e.g., a substantiallyspherical shape) with a substantially continuous outer surface asdescribed above for previous embodiments.

A suture strand 3835 extends along the length of the occlusion device3810 to provide reinforcement to the occlusion device 3810 and can alsoprovide for a radiopaque coil to be disposed over at least a portion ofthe suture strand 3835 to provide visibility of the occlusion device3810 during, for example, fluoroscopy. The suture strand 3835 can becoupled to, for example, marker bands 3842 and 3844 disposed on aproximal end and a distal end, respectively, of the occlusion device3810.

As shown in FIG. 38, the occlusion device 3810 can also include alead-in member 3876 coupled to a distal end portion of the occlusiondevice 3810 with the marker band 3844. The lead-in member 3876 can beformed the same as or similar to the lead-in members described above.Although not shown, the occlusion device 3810 can also include acoupling member to releasably couple the occlusion device 3810 to adelivery device as described above for previous embodiments.

In this embodiment, the first petal segment 3892, the second petalsegment 3891 and the third petal segment 3890 can be formed as separatecomponents and coupled together by the suture strand 3835. This createsa first articulation point or joint 3879 between the first petal segment3892 and the second petal segment 3891, and a second articulation pointor joint 3879′ between the second petal segment 3891 and the third petalsegment 3890. In this embodiment, the first petal segment 3892 includesthe marker band 3844 on a distal end and a marker band 3897 on aproximal end, the second petal segment 3891 includes a marker band 3896on a distal end and a marker band 3895 on a proximal end, and the thirdpetal segment 3890 includes the marker band 3842 at a proximal end and amarker band 3894 at a distal end. The first articulation joint 3879 isdefined where the marker band 3897 and the marker band 3896 are coupledto the suture strand 3835, and the second articulation joint 3879′ isdefined where the marker band 3895 and the marker band 3894 are coupleto the suture strand 3835.

As discussed above for occlusion device 3710, the articulation joints3879, 3879′ can provide greater freedom of motion of the petal-likeportions 3825 of the occlusion device 3810, which can allow more uniformexpansion of the petal-like portions 3825 within an aneurysm. Inaddition, with three petal segments 3892, 3891, 3890, the occlusiondevice 3810 can have a greater density when deployed within an aneurysmwhich can further enhance thrombosis.

In alternative embodiments, an occlusion device can have a differentnumber of articulation joints and a different number of petal segmentsthan described above for occlusion devices 3710 and 3810. In sonicembodiments, it may be desirable to have at least two petal-likeportions (e.g., 3725, 3825) between the articulation joints. In otherwords it may be desirable for each petal segment to have at least twopetal-like portions. A greater number of articulation points or jointscan provide increased freedom of motion of the petal-like portions,which can lead to a more uniform expansion of the occlusion device. Thepetal segments or layers can also have variable stiffness. For example,in an occlusion device, such as, occlusion device 3810, it may bedesirable for the first petal segment to have a greater stiffness suchthat the first petal segment (e.g., petal segment 3892) can frame theaneurysm as the occlusion device is being deployed within the aneurysm.In this example it may be desirable for the second petal segment (e.g.,petal layer 3891) to have a medium stiffness (e.g., stiffness less thanthe first petal segment and greater than the third petal segment) tofill the aneurysm, and the third petal segment (e.g., petal segment3890) to be the softest segment to pack the aneurysm.

The petal width can also be varied between segments. For example, it maybe desirable for the distal segment (e.g., first petal segment 3892) tohave a greater width than the remaining segments and the proximal petalsegments (e.g., the second petal segment 3891 and/or the third petalsegment 3890) to be shorter and narrower to fit inside the distalsegment (e.g., the first petal segment 3892).

Any of the occlusion devices described herein can include an outermarker band and an inner marker band coupled to a proximal end portionof the occlusion device that can be used to couple the occlusion deviceto an insertion device. In addition, any of the occlusion devicesdescribed herein can include a connector member (e.g., 2152, 3052, 3452)as described above, including a wire and ball member configured to becoupled to an insertion device. Further, although the ball members(insertion or implant ball members) are shown as circular, any of theball members described herein can be other shapes, such as, for example,oval, elliptical, square, rectangular, triangular or other desired shape(as shown in a side view).

The various devices described herein can be made of any materialsuitable for the defined purpose, including, for example, drawn filledtube DFT®. DFT is available as wire, cable or ribbon. DFT is ametal-to-metal composite developed to combine the desired physical andmechanical attributes of two or more materials into a single wire orribbon system, which can be used for the occlusion device.

Filaments or wires for the braid or mesh (e.g., the occlusion devices)can include, for example, filaments of materials such as MP35N,stainless steel, nitinol, cobalt chromium, titanium, platinum, tantalum,tungsten, or alloys thereof, or polyester, polyethylene (PET), Dacron,PEEK, vectron, and suture materials. Each strand may have a diameterbetween 0.0005″-0.010″, e.g., about 0.002″. In some embodiments, anouter material of the mesh or braid can be formed with nitinol that issuperelastic at body temperature, and an inner material can beradiopaque, or alternatively platinum wires may be included in the braidto provide additional radiopacity. For example, in some embodiments, anocclusion device can include radiopaque material(s) woven within themesh material such that the occlusion device can be highly visiblewithout the use of a radioactive die.

Suitable materials can be chosen based on their electropositivity. Forexample, an occlusion device can include titanium, tungsten, or anothermaterial listed below in Table 1, or any combination thereof. In use,the electropositive material of the expanded occlusion device creates anelectrically favorable region within the vascular defect and through theblood, and the region in the defect containing blood, fluid or tissue isthen predisposed for endothelialization to occur.

TABLE 1 PERIODIC COMPOSITE TABLE CHARGE ELEMENT ABBREVIATION FULL NAMEVALUE 22 Ti titanium 1.36 23 V vanadium 1.53 40 Zr zirconium 1.22 41 Nbniobium or 1.33 columbium 42 Mo molybdenum 1.47 72 Hf hafnium 1.16 73 Tatantalum 1.30 74 W tungsten 1.47

In some embodiments, the occlusion devices described herein can beformed with tubular braid, or sheets of woven filaments (forming a mesh,weave or fabric). The filaments can be wire or polymer or other suitablematerial. The occlusion devices can be braided wire (e.g. NiTi wire),and can include a mixture of wire types and wire sizes (e.g. NiTi andPlatinum wire, and e.g. 0.001″ wire braided with 0.00125″ wire). Theocclusion devices can also be made with polymer fibers, or polymerfibers and metal wire mixed together. In some embodiments, the filamentsor wires for the braid or mesh can be formed with a radiopaque material.In some embodiments, the filaments or wires for the braid or mesh caninclude, for example, a wire coextruded with a platinum core surroundedby nitinol (NiTi). In other words, the wire includes two concentriccircles when viewed in a cross-sectional view, with the center or corewire being platinum, and the outer wire being nitinol. The percentage ofplatinum can be, for example, between 5% platinum to 50% platinum andseveral variations in between (e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%,45%). Said another way, a percentage of a diameter of the wire can be,for example 5% to 50% platinum. In some embodiments, the percentage ofplatinum to nitinol is 30% platinum and 70% nitinol. In someembodiments, the occlusion devices can be formed with one or morebioabsorbable materials. In some embodiments, after the occlusion deviceis formed, the mesh of the implant can be etched to remove an outeroxide layer. This can provide corrosion reduction and/or help thrombosisform faster.

The occlusion devices described herein can be formed with one or moresoft pliable materials such that the occlusion device can be deployed,for example, in a ruptured or unruptured aneurysm. In some embodimentsan occlusion device as described herein can be formed with one or morematerials such that the occlusion device has variable stiffness. Forexample, a first portion of the occlusion device can be formed with afirst material and a second portion of the occlusion device can beformed with a second material different than the first material, or thefirst material can have a different thickness than the second material.For example, in some embodiments, a distal end portion of the occlusiondevice can be formed with a first material and a proximal end portion ofthe occlusion device can be formed with a second material different thanthe first material. In some embodiments, a proximal end portion of anocclusion device can be formed with a first material that provides forgreater stiffness than a second material with which a distal end portionof the occlusion device is formed. Such an embodiment may be desirablesuch that the softer distal end portion of the implant can be deployedwithin an aneurysm and the stiffer proximal end portion can provide morestructure to help support the implant at, for example, a neck of theaneurysm.

The mesh of the occlusion devices can be made by a variety of differentforms, including, but not limited to, braiding, weaving, welding, orlaser cutting. The mesh can have an operating length, for example, in arange of about 0.5 cm to about 70 cm. In some embodiments, the mesh canhave a length of 30 cm. In some embodiments, the mesh can have adiameter in a range of about 0.5 mm-60 mm. In some embodiments, the meshcan have a diameter of up to about 10 mm when expanded (e.g., about 9.5mm for an outer porous member or portion, about 8 mm for an inner porousmember or portion). The mesh can have a single density or can have twoor more densities. For example, in some embodiments, the number ofvariable densities can be in a range of about 2 to about 10. Forexample, a first density can be about 100 PPI and a second density canbe about 40 PPI (PPI=pics per inch). The braid pattern can be anypattern suitable, for example, a one-over-one configuration, ortwo-over-one configuration, etc. Strand count for the mesh can be in arange of about 4 strands to about 288 strands. In some embodiments, thestrand count is about 48 strands. Common multiples of 4, 8, 16, 24, 32,64, 72, 96, 128, 144, 192 and 288 strands for braid are available usingcommercial braiders.

A single occlusion device can include wires of the same size or acombination of 2 different wire sizes. For example, the occlusion devicecan have 24 wires of 0.001″ and 24 wires of 0.0005″. The thicker wirescan impart additional strength to the occlusion device and the thinnerwire can provide density. In addition, any combination of wire count,wire diameter, braid angle or pics per inch can be used to make the meshof the occlusion device.

Although the embodiments (e.g., occlusion device 2210) illustrated anddescribed herein include one or two porous members or portions (e.g.,porous members 2220, 2230), in other embodiments, any suitable number ofporous members or portions can be included. For example, in someembodiments, the occlusion device 2210 can also include a third porousmember (not shown) having a first end and a second end and coupled to atleast one of the first porous member 2220 and the second porous member2230. Like the first and second porous members 2220, 2230, the thirdporous member can have a collapsed configuration for insertion throughthe blood vessel and an expanded configuration for occupying the sac ofthe aneurysm. The third porous member can be substantially elongate andhave a width in its expanded configuration that is greater than itswidth in its collapsed configuration.

5.0 Conclusion

Although many of the embodiments are described above with respect todevices, systems, and methods for treating a cerebral aneurysm, otherapplications and other embodiments in addition to those described hereinare within the scope of the technology. For example, the occlusiondevices, systems, and methods of the present technology can be used totreat any vascular defect and/or fill or partially fill any body cavityor lumen or walls thereof. Additionally, several other embodiments ofthe technology can have different states, components, or procedures thanthose described herein. For example, in some aspects of the presenttechnology, the occlusion device 100 includes more than one mesh 101and/or braid. In further aspects, the mesh 101 is not a braidedstructure. Moreover, although the proximal portion 104 of the occlusiondevice 100 is described herein with reference to the particular meshconfiguration 101 shown in FIGS. 1A-3B, the intermediate and distalportions 106, 108 of the present technology can be used with anysuitable vascular occlusion device. For example, the intermediate anddistal portions 106, 108 of the present technology can be used with anyof the expandable implants described with reference to FIGS. 13A-38.

It will be appreciated that specific elements, substructures,advantages, uses, and/or other features of the embodiments describedwith reference to FIGS. 1A-4E and 6-12 can be suitably interchanged,substituted or otherwise configured with one another in accordance withadditional embodiments of the present technology. For example, theportions of the occlusion devices described with reference to FIGS. 6-12can be combined with any of the occlusion devices shown in FIGS. 1A-4E.Furthermore, suitable elements of the embodiments described above withreference to FIGS. 1A-4E and 6-12 can be used as standalone and/orself-contained devices. A person of ordinary skill in the art,therefore, will accordingly understand that the technology can haveother embodiments with additional elements, or the technology can haveother embodiments without several of the features shown and describedabove with reference to FIGS. 1A-4E and 6-12.

I/We Clause:
 1. A vascular occlusion device for treating an aneurysm,wherein a neck of the aneurysm opens to a blood vessel, the devicecomprising: a proximal portion having a mesh configured to be positionedwithin the aneurysm; a distal portion including a directing regionhaving: a proximal terminus that coincides with a proximal terminus ofthe distal portion, a distal terminus, wherein the directing regionextends along a first direction that runs through the proximal terminusand the distal terminus, and a length measured along the firstlongitudinal direction between the proximal terminus and the distalterminus; and an intermediate portion between the proximal and distalportions that, when in a deployed configuration, forms a preset bend inthe device that orients the first longitudinal direction of thedirecting region at an angle to a portion of the proximal portionadjacent the intermediate portion, and wherein, when the device is beingpushed distally out of a delivery catheter into the aneurysm, thedirecting region directs the distal portion to inhibit the distalportion from exiting the aneurysm through the neck such that theproximal portion crosses the neck and generally remains within theaneurysm.
 2. The device of claim 1 wherein the directing region includesan elongated, generally cylindrical portion of the mesh.
 3. The deviceof claim 1 wherein: the intermediate portion includes a portion of themesh having a preset, curved shape; and the directing region includes anelongated, generally cylindrical portion of the mesh.
 4. The device ofclaim 1 wherein the directing region has a generally linear shape. 5.The device of claim 1 wherein the proximal portion has a secondlongitudinal direction immediately adjacent the intermediate portion,and wherein the angle is between the first longitudinal direction of thedirecting region and the second longitudinal direction of the proximalportion.
 6. The device of claim 1 wherein the mesh is a braid.
 7. Thedevice of claim 1 wherein the length of the directing region is fromabout 25% to about 75% of a diameter of the aneurysm.
 8. The device ofclaim 1 wherein the length of the directing region is between about 0.05inches and about 0.20 inches.
 9. The device of claim 1 wherein thelength of the directing region is between about 0.021 inches and about0.20 inches.
 10. The device of claim 1 wherein the length of thedirecting region is between about 0.021 inches and about 0.18 inches.11. The device of claim 1 wherein the angle is between about 45 degreesand about 135 degrees.
 12. The device of claim 1 wherein the angle isbetween about 65 degrees and about 115 degrees.
 13. The device of claim1 wherein the angle is between about 70 degrees and about 110 degrees.14. The device of claim 1 wherein the angle is between about 80 degreesand about 105 degrees.
 15. A vascular occlusion device for treating ananeurysm, wherein a neck of the aneurysm opens to a blood vessel, thedevice comprising: an expandable mesh having an elongated configurationand a deployed configuration, wherein, in the deployed configuration,the mesh includes: a proximal portion formed of a flattened tubularbraid configured to contact and conform to an inner surface of theaneurysm, a radially compacted distal portion, an intermediate portionextending between the proximal portion and the distal portion, whereinthe intermediate portion is curved such that the distal portion ispositioned at a predetermined angle with respect to the proximalportion; and a directing region at the distal portion of the expandablemesh having a proximal terminus and a distal terminus, wherein thedirecting region extends along a first longitudinal direction that runsthrough the proximal terminus and the distal terminus, and wherein thedirecting region is positioned at an angle relative to the proximalportion between about 45 degrees and about 135 degrees, and wherein,when the device is being pushed distally out of a delivery catheter intothe aneurysm, the directing region directs the distal portion to inhibitthe distal portion from exiting the aneurysm through the neck such thatthe proximal portion crosses the neck and generally remains within theaneurysm.
 16. The device of claim 15 wherein the directing regionincludes an elongated, generally cylindrical portion of the mesh. 17.The device of claim 15 wherein the directing region has a generallylinear shape.
 18. The device of claim 15 wherein the proximal portion ofthe mesh forms a predetermined three-dimensional structure when the meshis in a deployed configuration.
 19. The device of claim 15 wherein theproximal portion of the mesh forms a plurality of curved, broad portionsthat together form a three-dimensional spherical structure when the meshis in the deployed configuration.
 20. The device of claim 15 wherein,when the mesh is in the deployed configuration, the proximal portion ofthe mesh forms (1) a first plurality of concave, broad portions thattogether form a first three-dimensional structure, and (2) a secondplurality of concave, broad portions that together form a secondthree-dimensional structure that is configured to be deployed within aninterior region defined by the first three-dimensional structure.